Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling OSTEORAPTOR 2.3 W 1UB II BLUE 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 source text describes a potential breach of the sterile barrier without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not yet been reported.
Plain-English summary
Smith & Nephew, Inc. is recalling the OSTEORAPTOR 2.3 W 1UB II BLUE absorbable suture anchor, Product Number 72201991. The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The affected batch numbers are listed in the structured product information.
The recall is being conducted 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 specific suture anchors 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
- OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
- 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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