FDA Medical Device Recalls (openFDA)
Zimmer Surgical Inc: Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
- Recall number
- Z-1485-2013
- Recalling firm
- Zimmer Surgical Inc
- Product
- Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
- Status
- Terminated
- Initiated
- 2013-05-07
- Posted
- 2013-06-05
- Terminated
- 2014-12-15
- Reason
- 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
- 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 dover.repairs@zimmer.com . 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 CorporateQualitv.PostMarket@zimmer.com. 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. PostMarket@zimmer.com or call 1-330-364-0989.
- Quantity
- 13 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.
- Lot, serial or model codes
- Serial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFD
- Firm FEI
- 1526350
- Firm city
- Dover
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28