Recall Z-1078-2024 ยท FZW Expander, Surgical, Skin Graft
Zimmer Surgical Inc
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
| Date | Feb 13, 2024 (initiated Jan 2, 2024) |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.