BIORAPTOR Suture Anchors (Smith & Nephew) – packaging sterility breach (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Brand
Smith & Nephew Inc.
Lot Codes / Batch Numbers
Part No. 72201541, 72201542, 72203280, 72203281, UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469, Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Products Sold
Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Smith & Nephew Inc. is recalling BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. due to Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to FieldActions@smith-nephew.com. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questions about this recall are to be emailed to FieldActions@smith-nephew.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026