Smith & Nephew Recalls TWINFIX ULTRA Absorbable Suture Anchors
Smith & Nephew is recalling TWINFIX ULTRA 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 involves a potential breach of the sterile barrier without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES absorbable suture anchors (Product Number: 72202616). The recall involves 263,874 units distributed nationwide and in numerous foreign countries. The specific batch numbers affected are 2025074, 2027489, 2031006, 2042572, 2052109, and 2056058.
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 that have received these products should stop using them and contact Smith & Nephew for instructions on return or replacement. Consumers are not expected to have direct access to these medical devices, but should contact their healthcare provider if they have questions regarding a recent procedure involving this product.
The recalled product
- Product
- TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
- 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: 2025074 2027489 2031006 2042572 2052109 2056058
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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