Smith & Nephew Recalls Microraptor Regenesorb Suture Anchors for Seal Issues
Smith & Nephew is recalling Microraptor Regenesorb Suture Anchors because improper or incomplete pouch 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 3/5 (High).
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 is classified as FDA Class II. The hazard involves a potential breach of the sterile barrier, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling the Microraptor Regenesorb Suture Anchor, an absorbable suture anchor (Product Number: 72204983). The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch numbers affected are 2034103, 2034102, 2034104, and 2042786.
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.
Healthcare providers and facilities should check their inventory for the affected product number and batch numbers. If the product is found, it should be removed from use and returned to Smith & Nephew, Inc. according to the company's instructions.
The recalled product
- Product
- MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Number: 72204983
- 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: 2034103 2034102 2034104 2042786
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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