Smith & Nephew Recalls OSTEORAPTOR Absorbable 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 263,874 units of OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE Absorbable Suture Anchors (Product Number: 72203290). The recall is due to improper or incomplete seals on the product packaging.
The defect may result in a breach of the sterile barrier created by the pouch surrounding the sterile product. The affected units were distributed nationwide and in numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
Healthcare providers and facilities should identify and stop using the affected suture anchors. Consumers are advised to contact their healthcare provider or the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- 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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