Device product
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
Z-0192-2016
Product summary
- Event
- Event 72360
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-0192-2016
Official wording
Reason: The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.
Code information: Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613
Distribution pattern: Worldwide distribution: US (nationwide) and country of: Canada.
Derived failure modes
-
Unknown
The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.