Smith & Nephew Recalls TWINFIX ULTRA HA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA HA absorbable suture anchors due to improper or incomplete packaging seals that 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 hazard is a potential breach of the sterile barrier. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK absorbable suture anchors (Product Number: 72202626). The recall is due to improper or incomplete seals on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch.
The affected product is distributed nationwide and in numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America. The specific batch numbers involved in this recall are 2012719, 2024702, 2027393, and 2029380.
Healthcare providers and facilities should check their inventory for these specific product numbers and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.
The recalled product
- Product
- TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202626
- Manufacturer
- Smith & Nephew, Inc.
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: 2012719 2024702 2027393 2029380
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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