BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Company
- Smith & Nephew, Inc.
- Recall Initiated
- October 29, 2024
- Posted
- November 29, 2024
- Recall Number
- Z-0581-2025
- Quantity
- 2,156 units
- Firm Location
- Andover, MA
Reason for Recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
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.
Lot / Code Info
Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Root Cause
Package design/selection
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.