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U.S. Department of Health and Human Services

Class 2 Device Recall 45mm Left Standard Offset Mandible

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 Class 2 Recall
45mm Left Standard Offset Mandible
see related information
Date Posted January 20, 2012
Recall Status1 Terminated on February 06, 2012
Recall Number Z-0823-2012
Recall Event ID 60910
Premarket Approval
PMA Number
P020016
Product Classification Mandibular Condyle Prosthesis - Product Code MPL
Product The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** Product Recall: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.
Code Information Product Part # 24-6646, lot # 080300
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Biomet Microfixation Inc sent an URGENT-Medical Device Recall notice to all consignees. The letter informs the customers to discontinue use of the items and return them to Biomet Microfixation.They also ask all customers to complete the inventory reconciliation sheet and return it by fax to the Global Complaint Coordinator. The letter also states that if the product was further distributed, the letter must be forwarded on to the firm's customers. For questions call 1-800-874-7711 or 904-741-4400, ext 468.
Quantity in Commerce 2 pieces
Distribution Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala.
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.
PMA Database PMAs with Product Code = MPL and Applicant = BIOMET MICROFIXATION
PMAs with Product Code = MPL and Applicant = BIOMET MICROFIXATION, INC.
PMAs with Product Code = MPL and Applicant = WALTER LORENZ SURGICAL, INC.
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