Class II — Greatbatch Medical
| Recalling firm | GREATBATCH MEDICAL |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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). |
| Quantity | 913 |
| Distribution | Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND. |
| Initiated | 2013-01-16 |
| Classified | 2013-01-30 |
| Terminated | 2014-09-16 |
| Recall number | Z-0751-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greatbatch Medical (Z-0751-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64129/
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