| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00950-1 |
| Product Name/Description |
VERSA-FX II Femoral Fixation System
Expiration Date: Prior to June 2023
Multiple Item Numbers affected (see attached)
ARTG Number : 112735 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration used for VERSA-FX II Femoral Fixation System, which consists of an inner and outer sterile tray, failed the leak test due to damage in the corner of the inner cavity. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is requesting hospitals to inspect the packages as described in the device package insert. If a inner package is determined to have been compromised, the device is to be quarantined and a Zimmer sales representative contacted. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |