The Recall Desk
ModerateFDA (Devices)·Z-2335-2016·Announced 2016-08-10

Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 220 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves surface coating degradation (blistering, peeling, discoloring) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Zimmer Surgical Inc is recalling 220 units of the Zimmer Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The recall is due to a defect where the surface coating applied to the device is blistering, peeling, and discoloring after usage over time.

The affected devices were distributed nationwide in the United States, including in the 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. The recall covers specific lot and serial number ranges, including Lot # 61987607 (Serial # 500041 – 500060) and Lot # 61989397 (Serial # 500061 – 500080), among others.

The Zimmer Air Dermatome II is a skin grafting instrument intended to provide variable graft thickness and width capabilities. Users should check their device against the listed lot and serial numbers and contact Zimmer Surgical Inc for further instructions.

The recalled product

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 produc
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
220

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Zimmer Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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