Z-2602-2018Class II

Zimmer Dermatone AN, Model No. 88710100

Name: Z-2602-2018 Zimmer Dermatone AN, Model No. 88710100
Creator: Zimmer Surgical Inc
Published: 2018-06-08
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2018-06-08 / Terminated

FDA source

Zimmer Surgical Inc began a recall of Zimmer Dermatone AN, Model No. 88710100 on 2018-06-08. FDA classified it as Class II and gives the reason as "Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2602-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-08
Posted: 2018-08-03
Terminated: 2019-07-19
Recalling firm: Zimmer Surgical SA
Product: Zimmer Dermatone AN, Model No. 88710100
Product code: GFD Dermatome
Reason for recall: Devices may have a loose control bar, which could compromise the ability to control the thickness of the graft. Devices could also have a loose width plate that if undetected, could result in an imperfect, yet still usable graft. Potential risks include harvesting a skin graft of a thickness much greater than intended, described as patient gouged, minor delay of surgery, and sub-optimal (but usable) graft.
FDA root cause: Under Investigation by firm
Action: On June 8, 2018, the firm distributed an Urgent Medical Device Recall letter to affected consignees. The letter alerted customers to the issue. Customers were asked to do the following: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your facility. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. Request an RGA number for each unit by calling 800-830-0970 or emailing [email protected]. d. Include a copy of Attachment 3 Certificate of Sterilization with returned instruments. e. Mark RECALL and RGA Number on the outside of the returned cartons. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 800-830-0970 between 8:00 am and 5:00pm 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].
Quantity in commerce: 140
Distribution: Distributors in AL, AZ, CA, FL, IA, IL, MA, MI, MN, MS, NH, NJ, NY, OH, RI, SD, and TX. Foreign distribution to Canada, Australia, China, and Netherlands.
Product codes and lots: Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2602-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2602-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code GFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)