Class 2 Device Recall Patient Distractor Driver

• Date Initiated by Firm: January 15, 2010
• Date Posted: April 11, 2010
• Recall Status: Terminated on May 14, 2010
• Recall Number: Z-1319-2010
• Recall Event ID: 54375
• Product Classification: Driver, Prosthesis - Product Code HWR
• Product: BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.
• Code Information: Lots: 459660, 478770, 530640.
• FEI Number: 1032347
• Recalling Firm/ Manufacturer: Biomet Microfixation, Inc.; 1520 Tradeport Dr; Jacksonville FL 32218-2480
• For Additional Information Contact: Christy Cain; 904-741-4400
• Manufacturer Reason for Recall: The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.
• FDA Determined Cause: Device Design
• Action: Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.
• Quantity in Commerce: 73
• Distribution: US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa
• 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.