Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0027-06 · Posted 2005-10-07

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2005-08-23
Date Terminated2005-12-08

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.

Firm Action

Consignees were notified via letter dated August 23, 2005 or by email.

Root Cause

Other

Distribution Pattern

Nationwide, Australia, Canada, England, Germany and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031449MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTIONImplex Corp. · 2003-09-23K022377THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306Implex Corp. · 2002-12-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑