FDA Device recall Z-0751-2013
45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031
- FDA Device
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of 45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031 by Greatbatch Medical, citing greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45¿ product line. Greatbatch has received reports of noisy and /….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0751-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-16 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Greatbatch Medical |
| Distribution | CA, IN, KS, MA, NJ, PA, TN, TX |
Product
45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
Reason
Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45¿ product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers.
Identifiers
| code_info | All lots |
|---|
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-0751-2013%22
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