FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03
- Recall number
- Z-0461-03
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03
- Status
- Terminated
- Initiated
- 2003-01-06
- Posted
- 2003-01-23
- Terminated
- 2003-12-04
- Reason
- Compression test results are not in accordance with device approval submission
- Root cause
- Other
- Action
- Products distributed to the U.S. market are being recalled via letter to users dated 1/6/2003, which was sent via certified mail. Customers are being asked to return product on hand to Zimmer.
- Quantity
- not on file
- Distribution
- United States.
- Lot, serial or model codes
- all lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- 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