3:1 Dermacarrier…

Date

Feb. 21, 2024

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Zimmer Surgical Inc

Product

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

Reason

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.

Distribution pattern

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.

Quantity

76 boxes (1,520 units) US; 521 boxes (10,420 units) OUS

Codes and lots

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

Recall started

Jan. 2, 2024

Device type

Expander, Surgical, Skin Graft

Root cause (FDA)

Under Investigation by firm

What the company told customers

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 CorporateQuality.PostMarket@zimmerbiomet.com.

Recall number

Z-1078-2024

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1078-2024. The agency record governs; check it and the company before acting.