Z-1078-2024Class II

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

Name: Z-1078-2024 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Creator: Zimmer Surgical Inc
Published: 2024-01-02
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2024-01-02 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer Surgical Inc began a recall of 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier on 2024-01-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1078-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-02
Posted: 2024-02-13
Recalling firm: Zimmer Surgical SA
Product: 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Product code: FZW Expander, Surgical, Skin Graft
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On January 2, 2024, the firm notified affected customers of the issue through URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to immediately notify affected personnel of the recall. Customers should also immediately locate and quarantine affected product in inventory. The customer may return the product to Zimmer Biomet, or a Zimmer Biomet sales representative may remove and return the product on the customer's behalf. If product has been further distributed, please notify your customers of the recall and ensure documentation. If you have further questions or concerns after reviewing this notice, please call Zimmer Biomet's customer service at 574-371-3071 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: 76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS
Distribution: 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.
Product codes and lots: UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1078-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-13

Product code FZW

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)