FDA Device recall Z-2051-2015
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX
- FDA Device
- Class II
- terminated
- Published 2015-07-15
On 2015-07-15 the FDA classified a Class II recall of TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX by Synthes, citing A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2051-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-03 |
| Published | 2015-07-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | MO, SC |
Product
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Reason
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Identifiers
| code_info | Part # 04.004.000, lot # 7950994 |
|---|
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-2051-2015%22
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