Lower riskMedical device recall · FDA · Published December 30, 2019
Smith & Nephew TwinFix Ti 2.8 mm Suture Anchor Recall: Sterile Barrier Risk
Smith & Nephew recalls TwinFix Ti 2.8 mm HS Suture Anchor due to potential sterile barrier breach from protective tube dislodging, risking device contamination.
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
“Smith & Nephew TwinFix Ti 2.8 mm Suture Anchor Recall: Sterile Barrier Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66192-smith-nephew-twinfix-ti-2-8-mm-suture-anchor-recall. Based on FDA recall #Z-1273-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1273-2020%22&limit=1).
The FDA announced on 2019-12-30 that Smith & Nephew, Inc. voluntarily recalled TwinFix Ti 2.8 mm HS Suture Anchors due to a potential sterile barrier breach. The agency classified the recall as Class II.
The hazard stems from a complaint indicating the protective tube of the device came off inside the pouch. This allowed the pointed end to puncture the package, breaching the sterile barrier and potentially affecting sterility.
Context
GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls on record since 2017-07-24. Other recent recalls of similar products include Smith & Nephew TRIGEN Humeral Nail Recall (2026-03-16), Smith & Nephew BIOSURE HA Screw Recall (2025-11-24), and Smith & Nephew META-TAN Screw Kit Recall (2025-03-18). Other recent recalls of similar products include Vortex Surgical I2 Injection Kit Recall (2025-12-16), Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), and Vortex Surgical 25GA I.D.D. Device Recall (2025-12-16).
How to tell if you have this one
Check for batch numbers: 2010547, 2025137, 2036695, 50763859, or 50773071. The product is a TwinFix Ti 2.8 mm HS Suture Anchor with part number 72200796.
Brand
Smith & Nephew
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Packaging
Inspect the protective tube for detachment inside the pouch; if it has come off, the device may be contaminated.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Idaho, Missouri, Nebraska, North Carolina, North Dakota, Oklahoma, South Carolina, Tennessee.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1273-2020 (December 30, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1273-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.