Recall Z-0751-2013— Greatbatch Medical
Class II · Terminated
Class II FDA medical device recall by Greatbatch Medical, initiated 2013-01-16, terminated 2014-09-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Greatbatch Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-16
- Terminated
- 2014-09-16
- Firm location
- Minneapolis, MN, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.