FDA Device recall Z-1678-2016
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm…
- FDA Device
- Class II
- terminated
- Published 2016-05-25
On 2016-05-25 the FDA classified a Class II recall of M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm… by Zimmer Manufacturing B V, citing A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1678-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-04 |
| Published | 2016-05-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 70 mm Length 00225307042
Reason
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Identifiers
| code_info | LOTS: 63295051 63293672 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1678-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.