| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00910-1 |
| Product Name/Description |
Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)
Multiple Item and Lot Numbers
ARTG Numbers: 112735 and 209302 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has discovered a raw material anomaly during an inspection of various trauma and extremity instruments (drill bits, screw taps and saw blades). An investigation by the supplier determined that four lots of raw material could have similar anomalies. The anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. The affected units were distributed between the dates of March 2016 and May 2017.
This issue may lead to extension of surgery < 30 minutes and/or the Patient retains piece of fractured instrument leading to patient injury.
This issue is not visually detectable in all cases. One injury has been reported internationally. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Biomet is conducting a lot specific recall for various trauma and extremity instruments (drill bits, screw taps and saw blades).
Hospital Responsibilities:
1.Review this notification and ensure affected personnel are aware of the contents;
2.Assist the Zimmer Biomet sales representative quarantine all affected product;
3.The Zimmer Biomet sales representative will remove the affected product from your facility;
4.Complete the supplied Attachment 1 – Certificate of Acknowledgement;
a.Return a digital copy to RAQA.ANZ@zimmerbiomet.com
b.Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |