CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

Zimmer Dermatone recalled by Zimmer Surgical

Zimmer Surgical is recalling Zimmer Dermatone AN, distributed in 17 states. The recall was initiated on 8 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373

Quantity recalled140

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2602-2018
FDA event ID: 80466
Recalling firm: Zimmer Surgical, Dover, OH
Classification: Class II
Status: Terminated
Recall initiated: 8 Jun 2018
FDA classified: 2 Aug 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Jun 2018	Recall initiated by company
2 Aug 2018	Classified by FDA	+55 days
8 Aug 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Zimmer Dermatone AN, Model No. 88710100

Where it was distributed

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.

Alabama Arizona California Florida Iowa Illinois Massachusetts Michigan Minnesota Mississippi New Hampshire New Jersey New York Ohio Rhode Island South Dakota Texas

Questions about this recall

Is Zimmer Dermatone AN recalled?

Yes. Zimmer Surgical recalled Zimmer Dermatone AN on 8 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2602-2018.

Why was it recalled?

Which lots are affected?

Lots 63578134 , 63578135, 63592351, 63618116, 63646910, 63817639, 63898373

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zimmer Surgical

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8 Jul 2026Device	CLASS II	Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled	Zimmer Surgical	Sterility	Nationwide
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24 Dec 2025Device	CLASS II	Zimmer Dermatome recalled by Zimmer Surgical	Zimmer Surgical	Other	OH

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