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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Distractor Driver

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  Class 2 Device Recall Patient Distractor Driver see related information
Date Initiated by Firm January 15, 2010
Date Posted April 11, 2010
Recall Status1 Terminated 3 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.
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 2		 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.
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