The Recall Desk
SevereFDA (Devices)·Z-2339-2016·Announced 2016-08-10

Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 90 units of Air Dermatome II Width Plates because the surface coating is blistering, peeling, and discoloring after use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class II, which corresponds to a Severe severity score under the rubric.

Plain-English summary

Zimmer Surgical Inc is recalling 90 units of the Zimmer Air Dermatome II Width Plate, 3 inch (Part #00-8851-203-00). The affected lots are 61999886, 62267473, 62339165, and 62606085. 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 agency has classified this recall as Class II.

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. Users should stop using the affected devices and contact Zimmer Surgical Inc for instructions on return or replacement.

The recalled product

Product
Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. 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
Affected units
90

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 # 61999886
  • Serial # N/A Lot # 62267473
  • Serial # N/A Lot # 62339165
  • Serial # N/A Lot # 62606085
  • 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 →