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U.S. Department of Health and Human Services

Class 2 Device Recall 3:1 Dermacarrier

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  Class 2 Device Recall 3:1 Dermacarrier see related information
Date Initiated by Firm January 02, 2024
Date Posted February 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-1078-2024
Recall Event ID 93790
Product Classification Expander, surgical, skin graft - Product Code FZW
Product 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Code Information UDI-DI 00889024378780 Lots 65292843 (Expires 16-Oct-2026) and 65390419 (Expires 18-Jan-2027)
Recalling Firm/
Manufacturer
Zimmer Surgical Inc
200 W Ohio Ave
Dover OH 44622-9642
For Additional Information Contact 411 Technical Services
574-371-3473
Manufacturer 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.
FDA Determined
Cause 2
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 CorporateQuality.PostMarket@zimmerbiomet.com.
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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