Smith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Seal Issues
Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a potential breach of the sterile barrier without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE Absorbable Suture Anchors (Product Number: 72201995). The recall is due to improper or incomplete seals on the pouch surrounding the sterile product, which may result in a breach of the sterile barrier.
The affected products were distributed nationwide and in numerous foreign countries, including the United States, Canada, and various locations in Europe, Asia, and South America. The source text lists specific batch numbers associated with this recall.
Consumers and healthcare providers should stop using the affected suture anchors and contact Smith & Nephew for further instructions on how to return or dispose of the product.
The recalled product
- Product
- OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Number: 72201995
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
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.
See all 40 products in this recall →Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighSmith & Nephew Recalls OSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
FDA (Devices) · 2013-09-25
- HighSmith & Nephew Recalls OSTOSTEORAPTOR Suture Anchors Due to Sterile Barrier Breach
FDA (Devices) · 2013-09-25
- HighSmith & Nephew Recalls Bioraptor Suture Anchors Due to Sterile Barrier Breach
FDA (Devices) · 2013-09-25
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Recalls RAPTORMITE Suture Anchors Due to Sterile Barrier Breach
FDA (Devices) · 2013-09-25
- HighSmith & Nephew Recalls TwinFix Ti Suture Anchors Due to Sterility Risk
FDA (Devices) · 2020-02-26