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U.S. Department of Health and Human Services

Class 2 Device Recall Vision RingLoc Acetabular System

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  Class 2 Device Recall Vision RingLoc Acetabular System see related information
Date Initiated by Firm July 28, 2015
Date Posted August 29, 2015
Recall Status1 Terminated 3 on May 17, 2016
Recall Number Z-2483-2015
Recall Event ID 71850
510(K)Number K093235  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
Code Information Part Number:135250; Lot Number:946410
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Seth Pixton
574-267-6639
Manufacturer Reason
for Recall		 The device was assembled without screw hole plugs.
FDA Determined
Cause 2		 Under Investigation by firm
Action Zimmer Biomet issued notices on July 28, 2015, via FedEx overnight mail and e-mail to customers. Customers were asked to return response forms and recalled devices to Zimmer Biomet. Customers with questions may call Seth Pixton, Field Action Specialist, at 574-372-1570, Monday through Friday from 8:00 am to 5:00 pm, or e-mail at: seth.pixton@zimmerbiomet.com.
Quantity in Commerce 5
Distribution Distributed in Canada and Japan.
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 = LPH and Original Applicant = BIOMET, INC.
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