The Recall Desk
ModerateFDA (Devices)·Z-2334-2016·Announced 2016-08-10

Zimmer Air Dermatome II Handpieces Recalled for Surface Coating Defects

Zimmer Surgical Inc is recalling 630 Air Dermatome II handpieces 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 defect involves surface coating degradation (blistering, peeling, discoloring) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Zimmer Surgical Inc is recalling 630 units of the Zimmer Air Dermatome II Handpiece, item number 00-8851-001-00. This skin grafting instrument is 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 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. The recall covers specific lot and serial number ranges, including Lot # 61977101 through Lot # 62635778.

Healthcare facilities and users should stop using the affected handpieces and contact Zimmer Surgical Inc for instructions on return or replacement. The FDA has classified this as a Class II recall, 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 Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
630

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)

  • Lot # 61977101
  • Serial # 500001  500019 Lot # 61980678
  • Serial # 500021  500040 Lot # 61989398
  • Serial # 500081  500090 Lot # 62008619
  • Serial # 500091  500110 Lot # 62083340
  • Serial # 500151  500170 Lot # 62096333
  • Serial # 500171  500190 Lot # 62122378
  • Serial # 500191  500210 Lot # 62191658
  • Serial # 500211  500230 Lot # 62191665
  • Serial # 500231  500250 Lot # 62220857
  • Serial # 500251  500270 Lot # 62220882
  • Serial # 500291  500310 Lot # 62244236
  • Serial # 500331  500350 Lot # 62266024
  • Serial # 500351  500371 Lot # 62267510
  • Serial # 500372  500391 Lot # 62267596
  • Serial # 500452  500471 Lot # 62289834
  • Serial # 500412  500431 Lot # 62309628
  • Serial # 500472  500491 Lot # 62309698
  • Serial # 500512  500531 Lot # 62369392
  • Serial # 500532  500551 Lot # 62374685

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

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Same hazard · surface coating defect

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