Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors for Seal Issues
Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging 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 barrier breach) 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/2 UB-BL CBR BL Absorbable Suture Anchors (Product Number: 72203706). The recall involves 263,874 units distributed nationwide and to numerous foreign countries. The specific batch numbers affected are listed in the agency's recall record.
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.
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
- HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- 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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