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.
What this means for you
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential breach of sterility, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Smith & Nephew, Inc. is recalling OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK absorbable suture anchors (Product Number: 72203291). The recall involves 263,874 units distributed nationwide and to numerous foreign countries.
The recall is being conducted because improper or incomplete seals on the product packaging may result in a breach of the sterile barrier created by the pouch. This defect could compromise the sterility of the medical device.
Healthcare providers and facilities should check their inventory for the affected batch numbers: 2012936, 2013911, 2016129, 2018794, 2027463, 2029395, and 2033280. Users should contact Smith & Nephew for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Number: 72203291
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 263,874
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Numbers: 2012936 2013911 2016129 2018794 2027463 2029395 2033280
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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