CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report

3:1 Dermacarrier, Model Number 00219501300, skin graft carrier recalled

Zimmer Surgical is recalling 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier, distributed nationwide in the US. The recall was initiated on 2 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)
Quantity recalled76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS

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-1078-2024
FDA event ID
93790
Recalling firm
Zimmer Surgical, Dover, OH
Classification
Class II
Status
Ongoing
Recall initiated
2 Jan 2024
FDA classified
13 Feb 2024
Reported
21 Feb 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

2 Jan 2024Recall initiated by company
13 Feb 2024Classified by FDA+42 days
21 Feb 2024Published in enforcement report+8 days

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

Reason for recall

Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.

Product as listed by the FDA

3:1 Dermacarrier, Model Number 00219501300, skin graft carrier

Where it was distributed

Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.

Nationwide CaliforniaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMichiganMissouriMontanaNorth CarolinaNevadaNew YorkOhioOklahomaPennsylvaniaRhode IslandTennessee

Questions about this recall

Why was it recalled?

Due to manufacturing issue, the product is labeled as 3:1 ratio, but the ridge pattern is a 1.5:1 ratio. The problem may lead to minor tissue damage or additional unplanned graft if deemed necessary.

Which lots are affected?

UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)

Where was it sold?

Worldwide - US Nationwide distribution including in the states of CA, DE, FL, GA, IA, IL, IN, KS, LA, MI, MO, MT, NC, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV and the countries of AUTRALIA, CANADA, DNIPRO OBLAS, HONG KONG, INDIA, JAPAN, MEXICO, CDMX, NETHERLANDS, SEOUL KOREA, SINGAPORE, TAIWAN, THAILAND.

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

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