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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 30, 2004
Recall Number Z-0710-04
Recall Event ID 28382
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
Product Biolox Ceramic Head XL
Code Information None apply.
Recalling Firm/
Plus Orthopedics
6055 Lusk Blvd
San Diego CA 92121
For Additional Information Contact Niel Delaney
Manufacturer Reason
for Recall
Ceramic femoral ball heads break.
FDA Determined
Cause 2
Action Firm is sending Dear Doctor letters to implanting physicians to have them evaluate their patients. Letters were sent 2/10/2004.
Quantity in Commerce 7 implanted.
Distribution To phyisicians in TX, CT, IN
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.