Device product
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
Z-1619-2013
Product summary
- Event
- Event 65166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 each of both units
- Official record key
device-enforcement:Z-1619-2013
Official wording
Reason: Incorrect blue/white suture was used.
Code information: Product Number CFBC-4502, Lot #431437
Distribution pattern: US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Derived failure modes
-
Unknown
Incorrect blue/white suture was used.