The Recall Desk
ModerateFDA (Devices)·Z-2340-2016·Announced 2016-08-10

Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 110 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, and the source text describes a surface coating defect (blistering, peeling, discoloring) without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.

Plain-English summary

Zimmer Surgical Inc is recalling 110 units of the Zimmer Air Dermatome II Width Plate, 4 inch (Part #00-8851-204-00). The device is a skin grafting instrument intended to provide variable graft thickness and width capabilities. 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 units were distributed nationwide in the United States, including in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, and Wisconsin. The specific lot numbers involved are 61999890, 62267474, 62339193, 62561320, and 62662647.

Healthcare providers and consumers should stop using the affected width plates and contact Zimmer Surgical Inc for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. 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 then
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
110

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 (6)

  • Lot # 61999890
  • Serial # N/A Lot # 62267474
  • Serial # N/A Lot # 62339193
  • Serial # N/A Lot # 62561320
  • Serial # N/A Lot # 62662647
  • 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 →

Related recalls

Same manufacturer · Zimmer Surgical Inc

See all →

Same hazard · surface coating defect

See all →