--- title: "Tornier, Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Tornier, Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/tornier-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Tornier, Inc recall records **10** reported ongoing 10 records in this archive. Latest source date Mar 5, 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 Mar 5, 2026 FDA device enforcement ### [Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER ...](https://isitonrecall.com/recall/fda-device-z-1769-2026-tornier-hrs-max-parts-1-tornier-hrs-max-tuberosity-body-lat-coat-small-cat-no-ars1041101-2-tornier-h/) Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI. [Official source for Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2....](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1769-2026%22) Dec 19, 2025 FDA device enforcement ### [TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318](https://isitonrecall.com/recall/fda-device-z-1237-2026-tornier-perform-reversed-perip-screw-5-0mmx18mm-non-sterile-catalog-number-dwj318/) A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1237-2026%22) Mar 3, 2025 FDA device enforcement ### [stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented](https://isitonrecall.com/recall/fda-device-z-1651-2025-stryker-latitude-ev-humeral-revision-stem-trial-l-150mm-size-large-side-right-ref-9030103-prosthesis/) A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red... Class II Reported ongoing Distribution: OUS (International) Distribution to countries: Sweden, Australia, United Kingdom, Colombia, Germany [Official source for stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103;...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1651-2025%22) Aug 29, 2024 FDA device enforcement ### [stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder](https://isitonrecall.com/recall/fda-device-z-3155-2024-stryker-tornier-perform-humeral-system-stemless-us-anatomic-nucleus-ref-dwm003a-anatomic-total-arthr/) One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, WI, AZ, NV, SD. [Official source for stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic tota...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3155-2024%22) Aug 29, 2024 FDA device enforcement ### [Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty](https://isitonrecall.com/recall/fda-device-z-3309-2024-stryker-tornier-perform-humeral-system-reversed-insert-45-ref-dwp2393-for-shoulder-arthroplasty/) Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3309-2024%22) Jan 3, 2024 FDA device enforcement ### [Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.](https://isitonrecall.com/recall/fda-device-z-0773-2024-stryker-tornier-perform-reversed-glenoid-press-fit-short-post-ti6ai4v-ref-dwj001-l-7mm-cementless-st/) The incorrect device is contained in the labeled package. Class II Reported ongoing Distribution: Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy. [Official source for Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cement...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0773-2024%22) Sep 15, 2023 FDA device enforcement ### [stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502](https://isitonrecall.com/recall/fda-device-z-0113-2024-stryker-tornier-perform-reversed-augmented-glenoid-lateralized-baseplate-25mm-offset-3mm-ref-dwj502/) One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. Class II Reported ongoing Distribution: US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN [Official source for stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0113-2024%22) Jun 12, 2023 FDA device enforcement ### [AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101](https://isitonrecall.com/recall/fda-device-z-2019-2023-aequalis-flex-revive-assembly-screw-0mm-model-number-ars655101/) A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. [Official source for AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2019-2023%22) Jun 12, 2023 FDA device enforcement ### [AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118](https://isitonrecall.com/recall/fda-device-z-2020-2023-aequalis-flex-revive-assembly-screw-0mm-short-model-number-ars655118/) A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. [Official source for AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2020-2023%22) May 3, 2022 FDA device enforcement ### [Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit](https://isitonrecall.com/recall/fda-device-z-1216-2022-ratcheting-screwdriver-handle-provided-in-the-aequalis-perform-reversed-kit/) The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1216-2022%22) ## Reasons in these listed records - Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. - A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of ea... - A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (co... - One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). These examples come from this result page and are not a ranking of every recall reason. ## Checking Tornier, Inc ### Is there a recall on tornier, inc right now? This archive contains 10 records, including 10 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 Tornier, Inc](https://isitonrecall.com/check/?q=Tornier%2C%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)