The Recall Desk
ModerateFDA (Devices)·Z-2336-2016·Announced 2016-08-10

Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 70 units of Air Dermatome II Width Plates 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, but the source text describes a surface coating defect (blistering, peeling, discoloring) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a defect with no reported harm.

Plain-English summary

Zimmer Surgical Inc is recalling 70 units of the Zimmer Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00. The affected lots are 61999883, 62243337, 62282028, and 62393990. The device is a skin grafting instrument intended to provide variable graft thickness and width capabilities.

The recall was initiated because the surface coating applied to the device is blistering, peeling, and discoloring after usage over time. The product was 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.

Consumers and healthcare facilities should stop using the affected width plates and contact Zimmer Surgical Inc for further instructions or a replacement.

The recalled product

Product
Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates 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, whic
Affected units
70

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 (5)

  • Lot # 61999883
  • Serial # N/A Lot # 62243337
  • Serial # N/A Lot # 62282028
  • Serial # N/A Lot # 62393990
  • Serial # N/A

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 →