Smith & Nephew Recalls TWINFIX Suture Anchors Due to Packaging Seal Issues
Smith & Nephew is recalling TWINFIX 6.5mm 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 is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX 6.5mm AB Preloaded Suture Anchors (Product Number 7210713) due to a defect in the product packaging. The recall involves 263,874 units distributed nationwide and in numerous foreign countries.
The recall was initiated because the packaging 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 device.
Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713
- 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: 2027380
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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