Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Defects
Smith & Nephew is recalling OSTEORAPTOR 2.3 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 precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchors (Product Number: 72201992). The recall involves 263,874 units distributed nationwide and to multiple foreign countries.
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.
Healthcare providers and facilities should check their inventory for the affected batch numbers listed in the recall notice. 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 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Number: 72201992
- 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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