Smith & Nephew Recalls Microraptor RegenSorb Suture Anchors for Seal Issues
Smith & Nephew is recalling Microraptor RegenSorb Suture Anchors because improper or incomplete pouch seals may breach the sterile barrier.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a breach of the sterile barrier could lead to infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling the Microraptor RegenSorb Suture Anchor (Product Number: 72204984). The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch number affected is 2042787.
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 suture anchor.
Healthcare providers and facilities should check their inventory for this specific product number and batch number. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to their instructions.
The recalled product
- Product
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204984
- 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: 2042787
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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