Reported Aug 10, 2016 · Terminated
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and…
Zimmer Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642
Is this the product you have?
- Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. 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 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 placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 Lot # 61987607, Serial # 500041 500060 2 Lot # 61989397, Serial # 500061 500080 3 Lot # 62007988, Serial # 500111 500130 4 Lot # 62008620, Serial # 500131 500150 5 Lot # 62244213, Serial # 500311 500330 6 Lot # 62267555, Serial # 500392 500411 7 Lot # 62289845, Serial # 500432 500451 8 Lot # 62309684, Serial # 500492 500511 9 Lot # 62374706, Serial # 500572 500591 10 Lot # 62393940, Serial # 500612 500631 11 Lot # 62415890, Serial # 500672 500691 - Amount recalled
- 220 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The surface coating applied to the device is blistering, peeling and discoloring after usage over time
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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