--- title: "Orthofix U.S. LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Orthofix U.S. LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/orthofix-u-s-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Orthofix U.S. LLC recall records **13** reported ongoing 13 records in this archive. Latest source date Jun 10, 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 Jun 10, 2026 FDA device enforcement ### [Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device](https://isitonrecall.com/recall/fda-device-z-2729-2026-orthofix-minirail-standard-lengthener-model-catalog-number-m101-unilateral-orthopedic-trauma-externa/) Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Class II Reported ongoing Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None [Official source for Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma e...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2729-2026%22) Jun 10, 2026 FDA device enforcement ### [Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation device](https://isitonrecall.com/recall/fda-device-z-2730-2026-orthofix-minirail-short-lengthener-ref-m103-unilateral-orthopedic-trauma-external-fixation-device/) Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Class II Reported ongoing Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None [Official source for Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation de...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2730-2026%22) Jun 10, 2026 FDA device enforcement ### [Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device](https://isitonrecall.com/recall/fda-device-z-2731-2026-orthofix-articulated-minirail-fixator-horizontal-axis-ref-m111-unilateral-orthopedic-trauma-external/) Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Class II Reported ongoing Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None [Official source for Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma ext...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2731-2026%22) Jun 10, 2026 FDA device enforcement ### [Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma external fixation device](https://isitonrecall.com/recall/fda-device-z-2732-2026-orthofix-minirail-articulated-fixator-vertical-axis-ref-m122-unilateral-orthopedic-trauma-external-f/) Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 Class II Reported ongoing Distribution: US: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA WI OUS: None [Official source for Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma ex...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2732-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X ...](https://isitonrecall.com/recall/fda-device-z-0891-2026-brand-name-construx-mini-ptc-spacer-system-product-name-construx-mini-ptc-spacer-system-model-catalo/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0891-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spa...](https://isitonrecall.com/recall/fda-device-z-0892-2026-brand-name-forza-ptc-spacer-system-product-name-forza-ptc-spacer-system-model-catalog-number-38-1007/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number:...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0892-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14...](https://isitonrecall.com/recall/fda-device-z-0893-2026-brand-name-pillar-sa-ptc-spacer-system-product-name-pillar-sa-ptc-spacer-system-model-catalog-number/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0893-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI ...](https://isitonrecall.com/recall/fda-device-z-0894-2026-brand-name-firebird-si-fusion-system-product-name-firebird-si-fusion-system-model-catalog-number-18/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Num...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0894-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer...](https://isitonrecall.com/recall/fda-device-z-0895-2026-brand-name-forza-ti-spacer-system-product-name-forza-ti-spacer-system-model-catalog-number-38-2006sp/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0895-2026%22) Nov 3, 2025 FDA device enforcement ### [Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X ...](https://isitonrecall.com/recall/fda-device-z-0896-2026-brand-name-construx-mini-ti-spacer-system-product-name-construx-mini-ti-spacer-system-model-catalog/) Labeling contains claims that are not consistently present. Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH,... [Official source for Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0896-2026%22) Sep 19, 2025 FDA device enforcement ### [Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-1075...](https://isitonrecall.com/recall/fda-device-z-0478-2026-virata-preassembled-polyaxial-screw-utilized-in-the-virata-spinal-fixation-system-the-following-size/) Polyaxial screws do not meet performance standards. Class II Reported ongoing Distribution: US Nationwide distribution in the states of California, North Carolina, and Texas. [Official source for Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0478-2026%22) Jun 24, 2025 FDA device enforcement ### [PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP](https://isitonrecall.com/recall/fda-device-z-2555-2025-pillar-sa-ti-sterile-37mm-w-x-28mm-d-x-18mm-h-20-degrees-ref-82-3713sp/) A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CO, CA. [Official source for PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2555-2025%22) Feb 20, 2025 FDA device enforcement ### [Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) ...](https://isitonrecall.com/recall/fda-device-z-1432-2025-orthofix-pillar-sa-ti-spacer-system-intervertebral-body-fusion-spinal-device-sterile-implant-grade-t/) The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. Class II Reported ongoing Distribution: US Nationwide distribution in the states of California, Colorado, and Missouri. [Official source for Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant gr...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1432-2025%22) ## Reasons in these listed records - Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 - Labeling contains claims that are not consistently present. - Polyaxial screws do not meet performance standards. - A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct. These examples come from this result page and are not a ranking of every recall reason. ## Checking Orthofix U.S. LLC ### Is there a recall on orthofix u.s. llc right now? This archive contains 13 records, including 13 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 Orthofix U.S. LLC](https://isitonrecall.com/check/?q=Orthofix%20U.S.%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)