Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
Smith & Nephew is recalling OSTEORAPTOR suture anchors because pinholes in primary pouches may breach the sterile barrier, posing a risk of infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect (sterile barrier breach) poses a significant risk of harm such as infection.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling the OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black (Part Number: 72203291). This biodegradable suture anchor is subject to a Class II recall by the U.S. Food and Drug Administration.
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 potentially compromise the sterility of the device.
The affected units were distributed worldwide, including in the United States, Canada, various European countries, and regions in Asia-Pacific, South America, and Africa. Healthcare providers and facilities should stop using the affected suture anchors and contact Smith & Nephew for further instructions on return or replacement.
The recalled product
- Product
- OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Affected units
- 4,946
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
Same manufacturer · Smith & Nephew, Inc. Endoscopy Division
See all →- HighSmith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
- SevereSmith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
FDA (Devices) · 2014-07-23
Same hazard · sterile barrier breach
See all →- ModerateBoston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk
FDA (Devices) · 2026-08-12
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- ModeratePhantom Hindfoot Guide Rods Recalled Due to Sterile Barrier Breaches
FDA (Devices) · 2026-07-29
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27