Device product
BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Z-0581-2025
Product summary
- Event
- Event 95654
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,156 units
- Official record key
device-enforcement:Z-0581-2025
Official wording
Reason: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Code information: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
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.
Derived failure modes
-
Labeling or packaging
inadequate packaging
-
Sterility assurance
Sterile barrier breach