FDA Device recall Z-1190-2017
Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip jo…
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip jo… by Greatbatch Medical, citing 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 compon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1190-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greatbatch Medical |
| Distribution | US |
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.
Identifiers
| code_info | 2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 28…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1190-2017%22
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