FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
- Recall number
- Z-0492-2014
- Recalling firm
- Aesculap, Inc.
- Product
- Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
- Status
- Terminated
- Initiated
- 2013-09-19
- Posted
- 2013-12-13
- Terminated
- 2014-12-22
- Reason
- The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
- Root cause
- Component change control
- Action
- Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.
- Quantity
- 24
- Distribution
- Distributed in FL and MD.
- Lot, serial or model codes
- lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597
- 510(k) numbers
- ["K083772","K122985"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- 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