CLASS II Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
Zimmer Air Dermatome II recalled by Zimmer Surgical
Zimmer Surgical is recalling Zimmer Air Dermatome II, distributed nationwide in the US. The recall was initiated on 7 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1484-2013
- FDA event ID
- 65258
- Recalling firm
- Zimmer Surgical, Dover, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2013
- FDA classified
- 5 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 May 2013 | Recall initiated by company | |
| 5 Jun 2013 | Classified by FDA | +29 days |
| 12 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Where it was distributed
Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 65258| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Zimmer Air Dermatome recalled by Zimmer Surgical | Zimmer Surgical | Other | Nationwide | |
| CLASS II | Zimmer Air Dermatome II recalled by Zimmer Surgical | Zimmer Surgical | Other | Nationwide |
More recalls from Zimmer Surgical
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Sterile Tourniquet Hoses A.T.S¿ 4000 TS Tourniquet Systems recalled | Zimmer Surgical | Sterility | Nationwide |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 5000TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Tourniquet Systems A.T.S.¿ 3200TS Tourniquet Systems recalled | Zimmer Surgical | Device Malfunction | OH |
| Device | CLASS II | Zimmer Dermatome recalled by Zimmer Surgical | Zimmer Surgical | Other | OH |
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