FDA recall Z-0069-2024

Zimmer Surgical Inc · Class II · device

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 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

Distribution

US Nationwide Foreign: AUSTRALIA BRAZIL CHINA HONG KONG INDIA JAPAN MALAYSIA MEXICO NETHERLANDS ON SEOUL SINGAPORE TAIWAN THAILAND

Key facts

Status
Ongoing
Initiation date
2023-09-05
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dover, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2024