Recall Z-1078-2024— Zimmer Surgical Inc
Class II · Ongoing
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2024-01-02. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-02
- Firm location
- Dover, OH, United States
Product description
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.