Recall Z-0581-2025
Smith & Nephew Inc. · initiated October 29, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Codes / lots: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Reason for recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
FDA-determined 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.
Details
- Recall number
- Z-0581-2025
- Initiated
- October 29, 2024
- Posted by FDA
- November 29, 2024
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 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.
- Recalling firm
- Smith & Nephew Inc., Andover, MA