| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01028-1 |
| Product Name/Description |
Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)
Item number: 42-5099-004-00
ARTG number: 109936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer has received complaints related to binding of the Distal Valgus Alignment Guide's Locking Knob. Persona Distal Valgus Alignment Guide collet locks are seizing in the 'Unlocked' position during normal operation. This seizure causes the diameter between the collet pegs to become smaller than that of the 8mm IM (Intramedullary) Rod and prevents the rod from being inserted or removed from the Alignment Guide rendering the device unusable. The root cause of the binding was determined to be excessive counter-clockwise rotation of the knob when unlocking the device. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer determined that additional guidance on the locking/unlocking feature was needed. Zimmer is requesting the customers to review the updated portion of the Persona surgical technique (97-5026-001-00) provided with the customer letter, which details use of the Adjustable Valgus Guide. This action has been closed-out on 07/06/2016. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |