Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: Recalled by Smith & Nephew, Inc. Due to Due to a potential for sterile barrier breach....
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Smith & Nephew, Inc. directly.
Affected Products
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Quantity: 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smith & Nephew, Inc.
Smith & Nephew, Inc. has 220 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report