The Recall Desk
ModerateFDA (Devices)·Z-2338-2016·Announced 2016-08-10

Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 60 units of the Air Dermatome II Width Plate 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 does not report any injuries, illnesses, or hospitalizations. The hazard is a surface coating defect (blistering, peeling, discoloring) without explicit mention of high-risk pathogens or structural failure leading to immediate harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Surgical Inc is recalling 60 units of the Zimmer Air Dermatome II Width Plate, 1.5 inch (Part #00-8851-215-00). The affected lots are 61999884, 62267513, and 62635782. 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 width plates are packaged inside a padded-foam corrugate box with a product label on the lid, or in a labeled poly zipper bag when sold individually.

The affected units were distributed nationwide in the United States, including 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. Users should stop using the affected devices and contact Zimmer Surgical Inc for further instructions.

The recalled product

Product
Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. 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
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
60

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 (4)

  • Lot # 61999884
  • Serial # N/A Lot # 62267513
  • Serial # N/A Lot # 62635782
  • 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 →

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Same hazard · surface coating defect

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