Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX AB 5.0 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 barrier breach) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX AB 5.0 Suture Anchors (Product Number: 72200785) due to a defect in the product packaging. The recall involves 263,874 units distributed nationwide and in numerous foreign countries.
The recall is being issued because the packaging may have an improper or incomplete seal on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch, potentially compromising the sterility of the medical device.
Healthcare providers and facilities that have received this product should stop using it and contact Smith & Nephew for further instructions. Consumers are advised to check with their healthcare provider if they have had this product used during a procedure.
The recalled product
- Product
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- 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 (1)
- Batch Numbers: 2044764
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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