Smith & Nephew Recalls TWINFIX Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling TWINFIX 6.5mm absorbable suture anchors because improper 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.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX 6.5MM AB PRELOADED ULTRABRAID Absorbable Suture Anchors, Product Number 7210712. The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch number affected is 2025178.
The recall was initiated because the product 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.
Healthcare providers and facilities should check their inventory for this specific product number and batch number. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.
The recalled product
- Product
- TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
- 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 (1)
- Batch Numbers: 2025178
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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