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Greatbatch Medical recalls Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplast
Recalled February 22, 2017 · FDA recall Z-1190-2017 · Greatbatch Medical
Hazard
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. · FDA Class II
Units
1,441
Sold at
Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
Description
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.
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.
Manufacturer(s)
Greatbatch Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →