Z-0751-2013Class II

45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662...

Name: Z-0751-2013 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662...
Creator: Greatbatch Medical
Published: 2013-01-16
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2013-01-16 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879... on 2013-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0751-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-16
Posted: 2013-01-30
Terminated: 2014-09-16
Recalling firm: Greatbatch Medical
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).
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Greatbatch sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 15, 2012 to all affected customers. The letter described the Reason For Recall, Risk to Health, and Instructions to Customers. Advised consignees to examine their inventory and quarantine the product in question. If they have further distributed the product to notify their customers and to complete and return the "Recall Response Form". Contact the firm at 1-763-951-8235 for questions relating to this notice.
Quantity in commerce: 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0751-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-30

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)