Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX 5.0MM AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a breach of the sterile barrier could lead to infection, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX 5.0MM AB Suture Anchors (Product Number: 7210711) due to a defect in the product packaging. The recall involves 263,874 units distributed nationwide and to numerous foreign countries.
The recall was initiated because the seal of the pouch surrounding the sterile product may be improper or incomplete. This defect may result in a breach of the sterile barrier created by the pouch, potentially compromising the sterility of the suture anchors.
Healthcare providers and facilities should check their inventory for TWINFIX 5.0MM AB Suture Anchors with Batch Numbers 2025421 or 2038665. If these products are found, they should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.
The recalled product
- Product
- TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 263,874
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch Numbers: 2025421
- 2038665
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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