Zimmer Dermatome AN, Model/Catalog Number: 88710100

FDA device recall Z-0925-2026 · posted 2025-12-15 · Open, Classified

Recall details

Recalling firm

Zimmer Surgical Inc

Reason for recall

The devices may have a misaligned thickness control bar.

Action taken

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 CorporateQuality.PostMarket@zimmerbiomet.com 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 product.experience@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 dover.repairs@zimmerbiomet.com and CorporateQuality.PostMarket@zimmerbiomet.com. b. Submit the completed Attachment 1 Recall Response Form for each return to Cor

Root cause

Process control

Status

Open, Classified

Product code

GFD

Quantity affected

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

Date initiated

2025-11-24

Date posted

2025-12-15

Location

Dover, OH