Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR 2.3 mm Suture Anchors because pinholes in primary pouches may breach the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for an implanted medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling OSTEORAPTOR 2.3 mm Suture Anchors with 1 ULTRABRAID COBRAID Suture, Black (Part Number: 72201992). The recall involves 18,919 units distributed worldwide, including the United States, Canada, Europe, Asia-Pacific, and other regions.
The recall was initiated because pinholes were detected in a small number of primary pouches. These pinholes may constitute a breach of the sterile barrier, which could compromise the sterility of the medical device.
Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 18,919
Distribution
Part of a larger recall action
This product is one of 26 recalled by Smith & Nephew, Inc. Endoscopy Division 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.
See all 26 products in this recall →Related recalls
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