| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00976-1 |
| Product Name/Description |
Zimmer Air Dermatome II Handpiece (used during skin grafting surgeries)
Item Number: 00-8851-001-00
All serial numbers affected
ARTG Number: 115929 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied to the device is blistering, peeling and discolouring after usage over time. There have been no injuries associated with the reported complaints. In addition, an independent assessment determined that the blistering, peeling and potentially flaking of the surface coating is not expected to result in any long range health consequences. Given that the frequency of this surface coating condition can worsen with age, Zimmer Biomet is currently making preparations for replacement activities to follow in order to prevent future complaints. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is advising users to inspect the devices before and after each use. If blistering or peeling is observed, discontinue use of the affected device. If an alternative device is not available, at the surgeon's discretion, determine the use of the device as a medical necessity and continue to use.
After use, follow the facilities wound irrigation protocol or Zimmer Biomet recommends copious irrigation with a normal saline solution or immersion of the graft in a bowl of normal saline. Zimmer Biomet recommends irrigating the donor site with saline as well. Carefully examine the skin graft and donor site for grey coating flakes and continue to irrigate as necessary.
All affected devices will be replaced with unaffected stock when available. This action has been closed out on 20/01/2017. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |