FDAFDA · Food and drugs·Recall number Z-0751-2013
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).
Published February 6, 2013 · Recall initiated: January 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Greatbatch Medical
- Distributor
- 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.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.