Z-0027-06

Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface...

Name: Z-0027-06 Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface...
Creator: Zimmer Inc.
Published: 2005-08-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2005-08-23 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA... on 2005-08-23. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0027-06
Status: Terminated
Initiated: 2005-08-23
Posted: 2005-10-07
Terminated: 2005-12-08
Recalling firm: Zimmer GmbH
Product: Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: 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.
FDA root cause: Other
Action: Consignees were notified via letter dated August 23, 2005 or by email.
Distribution: Nationwide, Australia, Canada, England, Germany and Italy.
Product codes and lots: All lots.

Product code KWS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)