Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece R... (Zimmer Surgical Inc) – this removal is in response to compla... (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Brand
Zimmer Surgical Inc
Lot Codes / Batch Numbers
Serial Number 500191, 500192, 500193, 500194, 500196, 500197, 500198, 500199, 500200, 500201, 500202, 500203, 500204, 500205, 500206, 500207, 500208, 500209, 500210, 500211, 500212, 500213, 500215, 500216, 500217, 500219, 500220, 500221, 500222, 500223, 500224, 500225, 500226, 500227, 500228, 500229, 500230, 500231, 500232, 500233, 500234, 500235, 500236, 500237, 500238, 500239, 500240, 500241, 500242, 500243, 500244, 500245, 500246, 500247, 500248, 500249, 500250, 500251, 500252, 500253, 500254, 500255, 500256, 500257, 500258, 500259, 500260, 500261, 500262, 500263, 500264, 500265, 500266, 500267, 500268, 500269, 500270, 500291, 500292, 500293, 500295, 500296, 500297, 500298, 500299, 500300, 500301, 500302, 500303, 500304, 500306, 500307, 500308, 500309, 500310, 500331, 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341, 500342, 500343, 500344, 500345, 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500357, 500358, 500359, 500368, 500369, 500370, 500371
Products Sold
Serial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223, 500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 , 500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259, 500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291, 500292,500293,500295,500296,500297,500298, 500299,500300,500301 , 500302,500303, 500304, 500306, 500307,500308,500309,500310, 500331 , 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341,500342, 500343, 500344, 500345, 500346, 500347, 500348,500349, 500350, 500351 , 500352, 500353, 500354,500355, 500357, 500358, 500359, 500368, 500369,500370,500371
Zimmer Surgical Inc is recalling Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments inte due to This removal is in response to complaints alleging that the Zimmer Air Dermatomes and Zimmer Air Dermatome II products would either not operate or ope. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Mar 8, 2026