The Recall Desk
ModerateFDA (Devices)·Z-1484-2013·Announced 2013-06-12

Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth

Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently.

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. The hazard involves device malfunction leading to surgical delays or suboptimal results, but no injuries, hospitalizations, or deaths are reported in the source text.

Plain-English summary

Zimmer Surgical Inc is recalling 126 units of the Zimmer Air Dermatome II handpiece, reference number 00-8851-001-00. These are prescription, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities. The affected units were distributed worldwide, including the United States, Puerto Rico, and various international locations such as Canada, Australia, and several countries in Europe and Asia.

The recall is in response to complaints alleging that the devices would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This defect may cause a delay or postponement of surgery or result in suboptimal graft retrieval, potentially requiring an additional donor site.

Healthcare facilities and users should stop using the affected units and contact Zimmer Surgical Inc for further instructions. The specific serial numbers affected are listed in the official recall notice.

The recalled product

Product
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Instrument
Hazard
Affected units
126

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 (20)

  • Serial Number 500191
  • 500192
  • 500193
  • 500194
  • 500196
  • 500197
  • 500198
  • 500199
  • 500200
  • 500201
  • 500202
  • 500203
  • 500204
  • 500205
  • 500206
  • 500207
  • 500208
  • 500209
  • 500210
  • 500211

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Zimmer Surgical Inc

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Same hazard · device malfunction

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