Device product
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
Z-1857-2017
Product summary
- Event
- Event 76729
- Status
- Terminated
- Classification
- Class II
- Quantity
- 197 units
- Official record key
device-enforcement:Z-1857-2017
Official wording
Reason: The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Code information: Batch numbers: (a) RES 74692410: 15GM13481, 15JM17474, 15JM17475 (b) RES 74692412: 15EM010131, 15JM07539 (c) RES 74692416: 15FM06118 (d) RES 74692422: 16AM19135 (e) RES 74692424: 15JM19559
Distribution pattern: Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
Derived failure modes
-
Labeling or packaging
labeling are incorrect