BIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
Smith & Nephew is recalling BIORAPTOR Suture Anchors due to inadequate packaging design that fails to maintain sterile barriers, potentially contaminating the implant. No injuries or illnesses have been reported.
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: This is an FDA Class II recall involving a sterile barrier breach on a surgical implant. The inadequate packaging design presents a clear risk of contamination, qualifying as a risk-of-harm product. However, no illnesses, injuries, or hospitalizations have been reported, keeping the severity at High rather than Severe per the rubric criterion for theoretical hazards without reported incidents.
Plain-English summary
Smith & Nephew Inc. is recalling BIORAPTOR Suture Anchors, which are non-bioabsorbable bone anchors used in tendon and ligament repair surgery. The recall is due to inadequate packaging design that cannot properly contain the device geometry, potentially causing a breach of the sterile barrier and contaminating the surgical implant.
The recalled product includes approximately 2,156 units distributed worldwide and within the United States across 13 states (Alaska, Alabama, Illinois, Indiana, Kentucky, Maryland, Minnesota, North Carolina, Nebraska, New Hampshire, New Jersey, and Texas), as well as international distribution to Canada, Chile, China, Ecuador, Spain, Great Britain, Kazakhstan, Norway, Peru, Poland, Russia, and Turkey. Specific batch numbers and UDI codes are available for identification.
Healthcare providers and patients who have received these implants should contact their physician if they have concerns. Smith & Nephew has not reported any confirmed illnesses or injuries related to this recall, though the sterile barrier breach presents a risk of device contamination.
The recalled product
- Product
- BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Manufacturer
- Smith & Nephew Inc.
- Hazard
- sterile-barrier-breach
- contamination-risk
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 (14)
- Part No. 72201541
- 72201542
- 72203280
- 72203281
- UDI-DI: 03596010595072
- 03596010595089
- 03596010656452
- 03596010656469
- Batch No. 2146369
- 2151242
- 2151690
- 2154691
- 2153489
- 2151692.
Distribution
Distributed nationwide across the United States.
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