BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
FDA device recall Z-0581-2025 · posted 2024-11-29 · Open, Classified
Recall details
- Recalling firm
- Smith & Nephew Inc.
- Reason for recall
- Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- MBI
- Quantity affected
- 2,156 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
- Date initiated
- 2024-10-29
- Date posted
- 2024-11-29
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.