Synthes Threaded Plate Holder- Long for 3 — Class II medical device recall Z-0192-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-11-04, distributed nationwide. The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit
| Recall number | Z-0192-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-10-07 |
| Classified | 2015-10-29 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 25 |
| Lot numbers | 324.031, 8225613 |
| Model numbers | 324.031, 8225613 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0192-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.