Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Issues
Smith & Nephew is recalling HEALICOIL absorbable 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 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 HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK Absorbable Suture Anchors (Product Number: 72203707). The recall involves 263,874 units distributed nationwide and to numerous foreign countries.
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 patients should check their inventory for the specific batch numbers listed in the official recall notice. 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
- HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
- Manufacturer
- Smith & Nephew, Inc.
- 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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