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
|
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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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