Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Issues
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 no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX 5.0mm AB Suture Anchors with Product Number 7210710. The recall involves 263,874 units distributed nationwide and in numerous foreign countries. The specific batch numbers affected are 2025362 and 2040057.
The recall is being conducted 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 the specific product number and batch numbers listed above. If the affected units are found, they should be removed from use and returned to Smith & Nephew, Inc. in accordance with the recall instructions.
The recalled product
- Product
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
- 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: 2025362
- 2040057
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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