Recall Z-1190-2017 ยท LXH Orthopedic Manual Surgical Instrument
Greatbatch Medical
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
| Date | Oct 19, 2016 |
| Status | Terminated |
| 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. |
| 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 FieldActionCenter@Greatbatch.com. For questions contact your local Greatbatch Medical representative, M |
| Quantity | 1,441 |
| Distribution | Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.