The Recall Desk
HighFDA (Devices)·Z-1483-2013·Announced 2013-06-12

Zimmer Air Dermatome Recalled for Broken Planetary Gear Teeth

Zimmer Surgical Inc is recalling 84 units of the Zimmer Air Dermatome because broken planetary gear teeth may cause the device to fail during surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (surgical delay, suboptimal graft, additional donor site) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Zimmer Surgical Inc is recalling 84 units of the Zimmer Air Dermatome (REF 00-8801-001-00), a prescription, non-sterile grafting instrument intended to provide variable graft thickness and width capabilities. The recall is in response to complaints 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 the surgery or result in a suboptimal graft retrieval, potentially requiring an additional donor site. The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), UAE, Taiwan, Sweden, Thailand, Korea, Singapore, Hong Kong China, Chile, Canada, Australia, Japan, England, Germany, and Egypt.

Healthcare providers should check their inventory for the specific serial numbers listed in the recall notice and stop using the affected devices. Patients who have had or are scheduled for procedures using these devices should contact their healthcare provider for more information.

The recalled product

Product
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , 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
84

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 100211
  • 100338
  • 100515
  • 100560
  • 100647
  • 100755
  • 101104
  • 101345
  • 101562
  • 101769
  • 101890
  • 101983
  • 102560
  • 103407
  • 103509
  • 103816
  • 104529
  • 104863
  • 105049
  • 105072

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 · mechanical failure

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