FDAFDA · Food and drugs·Recall number Z-2337-2016
Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
Published August 10, 2016 · Recall initiated: July 4, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer Surgical Inc
- Distributor
- US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
- Lot
- Lot # 61999885, Serial # N/A Lot # 62267472, Serial # N/A Lot # 62339198, Serial # N/A Lot # 62629006, Serial # N/A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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