FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246.
- Recall number
- Z-0028-06
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246.
- Status
- Terminated
- Initiated
- 2005-08-23
- Posted
- 2005-10-07
- Terminated
- 2005-12-08
- Reason
- The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Root cause
- Other
- Action
- Consignees were notified via letter dated August 23, 2005 or by email.
- Quantity
- not on file
- Distribution
- Nationwide, Australia, Canada, England, Germany and Italy.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K022377","K031449"]
- PMA numbers
- not on file
- Product code
- KWS
- 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