Device product
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Z-0325-2018
Product summary
- Firm
- Amendia, Inc
- Event
- Event 77991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 screws
- Official record key
device-enforcement:Z-0325-2018
Official wording
Reason: Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
Code information: Model #85-6560-1, Lot #132117
Distribution pattern: Distribution to Georgia, USA.
Derived failure modes
-
Labeling or packaging
Incorrect labeling