FDA Device recall Z-0604-2018
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile by Synthes Usa Products, citing the locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0604-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-21 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | GA, PA, TX, UT |
Product
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Reason
The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot.
Identifiers
| code_info | Lot H302839, Expiration Date 31Jan2026 |
|---|
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-0604-2018%22
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