Device product
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Z-0408-2018
Product summary
- Event
- Event 78672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-0408-2018
Official wording
Reason: One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Code information: 17AM14602
Distribution pattern: US Distribution to the state of OR, and Internationally to Colombia.
Derived failure modes
-
Unknown
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.