Device product
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700
Z-0329-2020
Product summary
- Event
- Event 83962
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,459,583 total devices
- Official record key
device-enforcement:Z-0329-2020
Official wording
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Code information: All products manufactured prior to January 2014.
Distribution pattern: Distributed nationwide.
Derived failure modes
-
Unknown
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).