Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling OSTEORAPTOR 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. The hazard is a potential breach of the sterile barrier due to packaging defects, which is a significant risk but does not meet the criteria for Severe (Class II with hospitalization reports) or Critical (Class I).
Plain-English summary
Smith & Nephew, Inc. is recalling OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE Absorbable Suture Anchors (Product Number: 72201994). The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch numbers affected are 2012769, 2013999, 2016154, 2021495, 2023224, 2025101, 2026924, 2027418, 2029364, 2030912, 2030913, 2033496, 2036691, 2049654, 2053758, and 2050886.
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 numbers 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
- OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Number: 72201994
- Manufacturer
- Smith & Nephew, Inc.
- 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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