FDA Recall Open, Classified

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Recall: Z-0924-2026 · Initiated November 24, 2025

Recall

Recall Number
Z-0924-2026
Event Number
98024
Firm
Zimmer Surgical Inc
FEI Number
1526350
Product Code
GFD
Status
Open, Classified
Root Cause
Process control
Initiated
November 24, 2025
Posted
December 15, 2025
Address
200 W Ohio Ave, Dover, OH, 44622-9642

Description

Zimmer Air Dermatome, Model/Catalog Number: 00880100100

Reason

The devices may have a misaligned thickness control bar.

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 your device was distributed over a year ago and likely has had multiple uses. If your device has had limited use, please contact [email protected] for instructions to return your device. 4. If you experience any adverse events with the affected devices, immediately cease use of the device and notify Zimmer Biomet by emailing [email protected]. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-613-6131 between 8:00 a.m. and 5:00 p.m. EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. A letter dated 11/24/25 was sent to Wave 1 of customers for product removal: Your Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. Immediately locate and return all affected products from your account to the Dover repair center. a. Prior to returning your devices, obtain a Work Order number by emailing Attachment 1 Recall Response Form to [email protected] and [email protected]. b. Submit the completed Attachment 1 Recall Response Form for each return to Cor

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 distribution and the identification of the domestic consignees.

Quantity

839 units