--- title: "Waldemar Link GmbH & Co. KG (Mfg Site) Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Waldemar Link GmbH & Co. KG (Mfg Site) recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/waldemar-link-gmbh-co-kg-mfg-site/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Waldemar Link GmbH & Co. KG (Mfg Site) recall records **58** reported ongoing 58 records in this archive. Latest source date Jul 6, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 6, 2026 FDA device enforcement ### [Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16](https://isitonrecall.com/recall/fda-device-z-2934-2026-endo-model-replacement-set-tibial-plateau-right-left-l-uhmwpe-cocrmo-rotating-hinge-item-number-15-0/) The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be ... Class II Reported ongoing Distribution: Domestic US distribution to Indiana. OUS distribution to Belarus and Germany. [Official source for Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item N...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2934-2026%22) Feb 11, 2026 FDA device enforcement ### [Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;](https://isitonrecall.com/recall/fda-device-z-1651-2026-embrace-drill-tower-wedged-25mm-item-number-645-081-62/) The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. Class II Reported ongoing Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA [Official source for Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1651-2026%22) Feb 11, 2026 FDA device enforcement ### [Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;](https://isitonrecall.com/recall/fda-device-z-1652-2026-embrace-drill-tower-standard-lateral-25mm-item-number-645-081-63/) The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. Class II Reported ongoing Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA [Official source for Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1652-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;](https://isitonrecall.com/recall/fda-device-z-1511-2026-endo-model-sl-connection-component-incl-pe-plateau-item-number-16-2840-05/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1511-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-0027/15;](https://isitonrecall.com/recall/fda-device-z-1512-2026-endo-model-replacement-plateau-item-number-15-0027-15/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/15;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1512-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;](https://isitonrecall.com/recall/fda-device-z-1513-2026-endo-model-sl-connection-component-incl-pe-plateau-item-number-16-2840-02/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1513-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;](https://isitonrecall.com/recall/fda-device-z-1514-2026-endo-model-sl-connection-component-incl-pe-plateau-item-number-16-2840-07/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1514-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-2835/12;](https://isitonrecall.com/recall/fda-device-z-1515-2026-endo-model-replacement-plateau-item-number-15-2835-12/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-2835/12;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1515-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-2836/11;](https://isitonrecall.com/recall/fda-device-z-1516-2026-endo-model-replacement-plateau-item-number-15-2836-11/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-2836/11;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1516-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-8030/12;](https://isitonrecall.com/recall/fda-device-z-1517-2026-endo-model-replacement-plateau-item-number-15-8030-12/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-8030/12;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1517-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-8521/09;](https://isitonrecall.com/recall/fda-device-z-1518-2026-endo-model-replacement-plateau-item-number-15-8521-09/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/09;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1518-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-8521/11;](https://isitonrecall.com/recall/fda-device-z-1519-2026-endo-model-replacement-plateau-item-number-15-8521-11/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/11;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1519-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-8521/15;](https://isitonrecall.com/recall/fda-device-z-1520-2026-endo-model-replacement-plateau-item-number-15-8521-15/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-8521/15;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1520-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-0027/11;](https://isitonrecall.com/recall/fda-device-z-1521-2026-endo-model-replacement-plateau-item-number-15-0027-11/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/11;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1521-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-0027/12;](https://isitonrecall.com/recall/fda-device-z-1522-2026-endo-model-replacement-plateau-item-number-15-0027-12/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/12;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1522-2026%22) Jan 12, 2026 FDA device enforcement ### [Endo-Model Replacement Plateau; Item Number: 15-0027/16;](https://isitonrecall.com/recall/fda-device-z-1523-2026-endo-model-replacement-plateau-item-number-15-0027-16/) The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Ne... [Official source for Endo-Model Replacement Plateau; Item Number: 15-0027/16;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1523-2026%22) Nov 10, 2025 FDA device enforcement ### [Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.](https://isitonrecall.com/recall/fda-device-z-0890-2026-endo-model-knee-fusion-nail-sk-knee-fusion-nail-coupling-component-right-modular-l-68-mm-taper-10-12/) The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. Class II Reported ongoing Distribution: US distribution to states of: AL, GA, and TX. [Official source for Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, T...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0890-2026%22) Jul 31, 2025 FDA device enforcement ### [LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50](https://isitonrecall.com/recall/fda-device-z-2541-2025-linksymphoknee-system-tibial-component-modular-symmetric-sz-5-cocrmo-tinbn-cemented-fixed-ref-number/) Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy. [Official source for LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2541-2025%22) Jul 15, 2025 FDA device enforcement ### [Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.](https://isitonrecall.com/recall/fda-device-z-2288-2025-prosthesis-head-b-28-mm-7-mm-neck-length-item-number-198-828-04/) Inconsistent size terminology and color coding used on labeling Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hunga... [Official source for Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2288-2025%22) Jul 15, 2025 FDA device enforcement ### [Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.](https://isitonrecall.com/recall/fda-device-z-2289-2025-plastic-trial-head-brown-7-mm-neck-length-item-number-175-928-15/) Inconsistent size terminology and color coding used on labeling Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hunga... [Official source for Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2289-2025%22) ## Reasons in these listed records - The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incor... - The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. - The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. - The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component. These examples come from this result page and are not a ranking of every recall reason. ## Checking Waldemar Link GmbH & Co. KG (Mfg Site) ### Is there a recall on waldemar link gmbh & co. kg (mfg site) right now? This archive contains 58 records, including 58 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Waldemar Link GmbH & Co. KG (Mfg Site)](https://isitonrecall.com/check/?q=Waldemar%20Link%20GmbH%20%26%20Co.%20KG%20%28Mfg%20Site%29) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)