Smith & Nephew Recalls TWINFIX AB 5.0 Suture Anchors Due to Seal Defects
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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX AB 5.0 Suture Anchors with Ultra-Absorbable Suture (Product Number 72200777). The recall involves 263,874 units distributed nationwide and in numerous foreign countries. The specific batch numbers affected are 2012914 and 2033371.
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, potentially compromising the sterility of the device.
Healthcare providers and facilities should check their inventory for the affected product number and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.
The recalled product
- Product
- TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777
- 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: 2012914
- 2033371
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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