Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors Due to Seal Defects
Smith & Nephew is recalling TWINFIX ULTRA absorbable 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 hazard is a potential breach of the sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL absorbable suture anchors (Product Number: 72202602). The recall involves 263,874 units distributed nationwide and to numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
The recall is due to improper or incomplete seals on the pouches 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 suture anchors.
Healthcare providers and facilities that have received these products should stop using them and contact Smith & Nephew for further instructions. Consumers are not directly affected as these are medical devices used in surgical procedures.
The recalled product
- Product
- TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Number: 72202602
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 263,874
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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