Reported Jun 12, 2013 · Terminated
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable…
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, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
- Lot codes and dates
126 of 126 codes
Serial Number 500191500192500193500194500196500197500198500199500200500201500202500203500204500205500206500207500208500209500210500211500212500213500215500216500217500219500220500221500222500223500224500225500226500227500228500229500230500231500232500233500234500235500236500237500238500239500240500241500242500243500244500245500246500247500248500249500250500251500252500253
- Amount recalled
- 126 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or operate intermittently. Zimmer's investigation determined that the planetary gear teeth were broken. This may cause a delay or postponement of the surgery or result in a suboptimal graft retrieval with potential of requiring an additional donor site.
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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