Recall Z-0069-2024— Zimmer Surgical Inc
Class II · Ongoing
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2023-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010. Reason: Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area.
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-05
- Firm location
- Dover, OH, United States
Product description
Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 00880000010
Reason for recall
Skin grafts thin and non-uniform when using the affected blades. The issue would be identified at the time of use and may result in the need for additional harvests to adequately cover the area
Data sourced from openFDA. This site is unofficial and independent of the FDA.