Class 2 Device Recall Bigliani/Flatow

• Date Initiated by Firm: August 23, 2005
• Date Posted: October 07, 2005
• Recall Status: Terminated on December 08, 2005
• Recall Number: Z-0024-06
• Recall Event ID: 33279
• 510(K)Number: K022377 K031449
• Product Classification: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented - Product Code KWS
• Product: Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-846-4637
• Manufacturer 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 Determined Cause: Other
• Action: Consignees were notified via letter dated August 23, 2005 or by email.
• Distribution: Nationwide, Australia, Canada, England, Germany and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWS and Original Applicant = IMPLEX CORP.