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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Signature " TKA GDE/MDL SET 0405

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 Class 2 Recall
Biomet Signature " TKA GDE/MDL SET 0405
see related information
Date Posted March 02, 2012
Recall Status1 Terminated on September 06, 2012
Recall Number Z-1145-2012
Recall Event ID 59740
Premarket Notification
510(K) Number
K102795 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in the guiding and marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Code Information Catalog number 42-422561 Lot numbers: 025565 & 025640
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Manufacturer Reason
for Recall
Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor's office as a product complaint.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action The firm, BIOMET Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated January 23, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Immediately locate and remove the above identified Signature " Guide and Model Set. -Carefully follow the instructions on the enclosed FAX Back Response Form. - Fax a copy of the Response Form to 574-372-1683 prior to return of product. - Use priority carrier for your shipment. - If you have further distributed this product, you MUST notify hospital personnel of this action, via the enclosed recall letter. This letter MUST be given to hospital personnel responsible for receiving recall notices. Confirm receipt of this notice by calling, 800-348-9500, extension 3983. Questions related to this notice should be directed to 574-372-3983, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 2 units
Distribution Nationwide distribution:Virginia and Ohio only.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = MATERIALISE N.V.
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