Z-1190-2017Class II

Offset Reamer Handle, T5766

Name: Z-1190-2017 Offset Reamer Handle, T5766
Creator: Greatbatch Medical
Published: 2016-10-19
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2016-10-19 / Terminated / root cause: design

FDA source

Greatbatch Medical began a recall of Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either... on 2016-10-19. FDA classified it as Class II and gives the reason as "On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1190-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-19
Posted: 2017-02-11
Terminated: 2019-03-08
Recalling firm: Greatbatch Medical
Product: Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel tube and outer housing.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.
Root cause tag: design
FDA root cause: Device Design
Action: Consignee was sent via e-mail on 10/16/2016 a Greatbatch "Urgent Medical Device Recall" letter dated 10/19/2016 The letter described the purpose of the letter, Reason for Notification, Risk to Health, Recommendation, Instruction to Zimmer. Advised consignee to examine their inventory, quarantine the product and provide a list of the affected countries where the product was distributed. Also requested consignee to complete the Customer Notification Response form and return to Greatbatch at [email protected]. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8235 8:00 AM (CT) to 5:00 PM (CT), or e-mail us at [email protected] .
Quantity in commerce: 1,441
Distribution: Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
Product codes and lots: 2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1190-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1190-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-10

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)