FDA Device recall Z-0192-2016
Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold by Synthes Usa Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0192-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-07 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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.
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.
Identifiers
| code_info | Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0192-2016%22
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