Z-0581-2025 Class II Ongoing
FDA device recall Z-0581-2025 was initiated by Smith & Nephew Inc. on October 29, 2024 and is designated Class II. Reason for recall: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device. The recall status is ongoing. Affected quantity: 2,156 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,156 units
Product Description
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Reason for Recall
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Distribution Pattern
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.
Code Information
Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.