Z-1484-2013Class II

Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to...

Name: Z-1484-2013 Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to...
Creator: Zimmer Surgical Inc
Published: 2013-05-07
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2013-05-07 / Terminated / root cause: manufacturing process

FDA source

Zimmer Surgical Inc began a recall of Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities on 2013-05-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1484-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-07
Posted: 2013-06-05
Terminated: 2014-12-15
Recalling firm: Zimmer Surgical SA
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
Product code: GFD Dermatome
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Zimmer, sent an "URGENT: DEVICE REMOVAL" notice dated May 7, 2013, to all consignees/customers via FED Ex and Distributors via E-mail. Consignees who had devices repaired received telephone calls as well as the mailed Recall Notice. The Notice identified the devices being recalled; possible adverse events and directions to immediately stop use of and remove affected product, and obtain an RGA (Return Goods Authorization) number by calling (800)348-2759 or email information to [email protected] . to return the devices for repair to:Zimmer Surgical, Attn: QA/RA Dept.- Recall, 200 West Ohio Avenue Dover, Ohio 44622 USA; and to complete and return the Response Form-Immediate Response Required via email to [email protected]. If you have further distributed affected product(s), please provide the customer's information on the Business Response Form to Zimmer. If you have any questions regarding this action, please email us at CorporateQuality. [email protected] or call 1-330-364-0989.
Quantity in commerce: 126 units
Distribution: Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1484-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1483-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1484-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1485-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05

Product code GFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)