FDA Device recall Z-1694-2015
Cortical Screw for M/DN Intramedullary Fixation
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of Cortical Screw for M/DN Intramedullary Fixation by Zimmer, citing the entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1694-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-29 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Reason
The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
Identifiers
| code_info | All lots. Part numbers: 00-2253-020-45 INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45 INTERLOCKING IM SCR…All lots. Part numbers: 00-2253-020-45 INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45 INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45 INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45 M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45 INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45 INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45 INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45 INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45 INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45 INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45 INTERLOCKING IM SCREW |
|---|
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-1694-2015%22
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