Recall Z-0925-2026 ยท GFD Dermatome
Zimmer Surgical Inc
Zimmer Dermatome AN, Model/Catalog Number: 88710100
| Date | Dec 15, 2025 (initiated Nov 24, 2025) |
| Status | Open, Classified |
| Reason | The devices may have a misaligned thickness control bar. |
| Root cause | Process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/24/25 was sent to customers. Zimmer Biomet is conducting a phased serial specific medical device recall for the Zimmer Air Dermatome and Zimmer Dermatome AN listed in Attachment 2 Affected Product List. Your Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. Due to the likelihood that the issue would occur upon the first few uses, affected devices that have not exhibited the issue may continue to be used until you receive the removal letter. 3. Our records indicate that |
| Quantity | 498 units |
| Distribution | Distribution regions: USA, Hong Kong, Thailand, Japan, Korea, Australia, Taiwan, India, Malaysia, Singapore, China, Canada, EMEA, Mexico, Trinidad & Tobago, Panama, Guatemala Refer to the attached ZFA 2025-00141_Initial Consignee List and ZFA 2025-001141_Initial Distribution History containing the |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.