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 involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though no injuries are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White (Part Number: 72201991). This biodegradable suture anchor is being recalled because pinholes were detected in a small number of primary pouches. These pinholes may constitute a breach of the sterile barrier.
The recall affects 22,879 units distributed worldwide, including the United States, Canada, Europe, Asia-Pacific, and other regions. The source text does not specify reported illnesses or injuries associated with this defect.
Healthcare providers and consumers should stop using the affected suture anchors and contact Smith & Nephew for instructions on return or replacement.
The recalled product
- Product
- OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 22,879
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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