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Recall Observatory FDA recall evidence

Device product

Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. 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.

Z-2335-2016

July 04, 2016

Class II

Product summary

Firm
Zimmer Surgical Inc
Event
Event 74636
Status
Terminated
Classification
Class II
Quantity
220 units
Official record key
device-enforcement:Z-2335-2016

Official wording

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

Code information: Lot # 61987607, Serial # 500041  500060 Lot # 61989397, Serial # 500061  500080 Lot # 62007988, Serial # 500111  500130 Lot # 62008620, Serial # 500131  500150 Lot # 62244213, Serial # 500311  500330 Lot # 62267555, Serial # 500392  500411 Lot # 62289845, Serial # 500432  500451 Lot # 62309684, Serial # 500492  500511 Lot # 62374706, Serial # 500572  500591 Lot # 62393940, Serial # 500612  500631 Lot # 62415890, Serial # 500672  500691

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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