| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01593-1 |
| Product Name/Description |
Greatbatch Medical Offset Reamer Handle
(used in total hip arthroplasty as interface between surgical drill and acetabular reamer)
Part Number: 00-7804-080-00
Lot Numbers: 56474941, 56474943, 56474944, 56474947, 56474982, 56474983, 56474990, 56596272, 56596277, 56596292, 56596366, 56596371, 56596428
ARTG Number: 266809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Greatbatch Medical has identified an issue with the 00-7804-080-00 Offset Reamer Handle, as field complaints were reported that the drive chain mechanism seizes during use. The function of the drive chain mechanism is to transmit rotational power from a mechanical drill to an acetabular reamer during a Total Hip Arthroplasty. During seizing, the device is rendered non-functional in the operating room.
The risks associated with this failure are:
1. The Offset Reamer Handle seizes and the surgery must be completed with an alternate device, leading to a delay of 30 minutes or greater from the scheduled surgery time.
2. The Offset Reamer Handle seizes and no replacement device is available in the hospital, leading to an interruption and rescheduling of surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is advising that a re-designed Offset Reamer Handle will be available in early 2017 and that customers will be notified once the replacements are available for delivery by Zimmer. In the interim, Zimmer is advising that a Straight Reamer Handle should be always be available and ready for surgical use and/or that a replacement or alternate Offset Reamer Handle, if desired, also be ready for use in a surgical procedure in or near the operating room. A Straight Reamer Handle device is commonly provided as part of the Reamer surgical set.
This action has been closed-out on 28/02/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |