Device product
Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
Z-0253-2018
Product summary
- Event
- Event 77039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0253-2018
Official wording
Reason: Manufactured with the incorrect anchor outer body
Code information: Lot Number 786351
Distribution pattern: CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
Derived failure modes
-
Unknown
Manufactured with the incorrect anchor outer body