Recall Z-0069-2024 ยท GFD Dermatome
Zimmer Surgical Inc
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
| Date | Oct 6, 2023 (initiated Sep 5, 2023) |
| Status | Open, Classified |
| Reason | Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area |
| Root cause | Process control |
| Action | Zimmer issued Urgent Medical Device Recall Letter (FA 2023-00208 ) to Distributors and Risk Managers and Recall FAQs to affected consignees on September 5, 2023. Letter states reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory. a. Your Zimmer Biomet sales representative may remove and return the affected product from your facility on your behalf. b. Alternatively, you may directly return |
| Quantity | 11,985 boxes (119,850 blades) |
| Distribution | US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.