PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 10, 2016 Initiated: July 4, 2016 #Z-2337-2016

Product Description

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.

Reason for Recall

The surface coating applied to the device is blistering, peeling and discoloring after usage over time

Details

Recalling Firm
Zimmer Surgical Inc
Units Affected
90 units
Distribution
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.
Location
Dover, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Surgical Inc. Units affected: 90 units.
Why was this product recalled?
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
Which agency issued this recall?
This recall was issued by the FDA Devices on August 10, 2016. Severity: Moderate. Recall number: Z-2337-2016.