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

FDA device recall Z-1078-2024 · posted 2024-02-13 · Open, Classified

Recall details

Recalling firm

Zimmer Surgical Inc

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FZW

Quantity affected

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,

Date initiated

2024-01-02

Date posted

2024-02-13

Location

Dover, OH