Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects
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, and the source text describes a potential breach of the sterile barrier without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew, Inc. is recalling OSTEORAPTOR 2.9 W 1UB II BLUE Absorbable Suture Anchors (Product Number: 72202165). The recall involves 263,874 units distributed nationwide and in numerous foreign countries, including the United States, Canada, and various nations in Europe, Asia, and South America.
The recall was initiated because the product packaging may have an improper or incomplete seal on the pouch surrounding the sterile product. This defect may result in a breach of the sterile barrier created by the pouch, potentially compromising the sterility of the device. The affected batch numbers are 2012722 and 2025144.
Healthcare providers and facilities should check their inventory for these specific product numbers and batch numbers. If the recalled products are found, they should be removed from use and returned to Smith & Nephew, Inc. in accordance with the company's instructions.
The recalled product
- Product
- OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
- 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: 2012722 2025144
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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