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
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
- Device type
- Other Medical Devices
Timeline
| 2 Jan 2024 | Recall initiated by company | |
| 13 Feb 2024 | Classified by FDA | +42 days |
| 21 Feb 2024 | Published 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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