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U.S. Department of Health and Human Services

Class 2 Device Recall Bigliani/Flatow

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  Class 2 Device Recall Bigliani/Flatow see related information
Date Initiated by Firm August 23, 2005
Date Posted October 07, 2005
Recall Status1 Terminated 3 on December 08, 2005
Recall Number Z-0025-06
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, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
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 2
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.
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