Recall Z-1190-2017— Greatbatch Medical

Class II FDA medical device recall by Greatbatch Medical, initiated 2016-10-19, terminated 2019-03-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Greatbatch Medical

Classification

Class II

Status

Terminated

Initiated

2016-10-19

Terminated

2019-03-08

Firm location

Plymouth, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.