Z-1190-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2017
- Initiation Date
- October 19, 2016
- Termination Date
- March 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,441
Product Description
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 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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
Code Information
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.