Reported Aug 10, 2016 · Terminated
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates…
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, 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 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
32 of 32 products
Products covered by this recall # Product as published 1 Lot # 61977101, Serial # 500001 500019 2 Lot # 61980678, Serial # 500021 500040 3 Lot # 61989398, Serial # 500081 500090 4 Lot # 62008619, Serial # 500091 500110 5 Lot # 62083340, Serial # 500151 500170 6 Lot # 62096333, Serial # 500171 500190 7 Lot # 62122378, Serial # 500191 500210 8 Lot # 62191658, Serial # 500211 500230 9 Lot # 62191665, Serial # 500231 500250 10 Lot # 62220857, Serial # 500251 500270 11 Lot # 62220882, Serial # 500291 500310 12 Lot # 62244236, Serial # 500331 500350 13 Lot # 62266024, Serial # 500351 500371 14 Lot # 62267510, Serial # 500372 500391 15 Lot # 62267596, Serial # 500452 500471 16 Lot # 62289834, Serial # 500412 500431 17 Lot # 62309628, Serial # 500472 500491 18 Lot # 62309698, Serial # 500512 500531 19 Lot # 62369392, Serial # 500532 500551 20 Lot # 62374685, Serial # 500552 500571 - Amount recalled
- 630 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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