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U.S. Department of Health and Human Services

Class 2 Device Recall MAK OSS No Head Lock Pin

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  Class 2 Device Recall MAK OSS No Head Lock Pin see related information
Date Initiated by Firm March 20, 2012
Date Posted April 19, 2012
Recall Status1 Terminated 3 on February 07, 2013
Recall Number Z-1438-2012
Recall Event ID 61089
510(K)Number K083779  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM UHMWPE
STERILE, R, Biomet Orthopedics Warsaw, IN 46581.

The MAK OSS No Head Metal Lock Pin is to be inserted into the anterior hole of the tibial bearing yoke to secure the OSS Axle in the correct position within the OSS Femoral component assembly.
Code Information Catalog number: CP113456 with lot numbers: 593310, 743610, 750120, 815030, and 815040.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Biomet initiated this action after receiving complaints of the MAK OSS No Head Lock Pin dislodging from its intended position (post-initial surgery). An investigation was initiated and the available lots of the Lock Pin were evaluated and measured against print specifications.
FDA Determined
Cause 2		 Component design/selection
Action Biomet sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated March 20, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to continue monitoring implanted patients for disassociation of the pin component and report to Biomet. The Alert included a complete listing of device invoice history and patient information (if supplied). Contact the firm for confirmation of receipt of the notice and for questions at 574-372-3983.
Quantity in Commerce 64 units distributed
Distribution Distributed in California and Pennsylvania.
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 = KRO and Original Applicant = BIOMET MANUFACTURING CORP.
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