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Class 3 Device Recall BIOMET MICROFIXATION SYSTEM BONE SCREW |
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Date Initiated by Firm |
October 06, 2009 |
Date Posted |
March 17, 2010 |
Recall Status1 |
Terminated 3 on April 07, 2010 |
Recall Number |
Z-1151-2010 |
Recall Event ID |
54372 |
510(K)Number |
K953385
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Product Classification |
Plate, bone - Product Code JEY
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Product |
BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.
Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed. |
Code Information |
Lot Numbers: 813480, 114360, 498480, 753270, WL2340 and 031830. |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
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For Additional Information Contact |
Christy Cain 904-741-4400
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Manufacturer Reason for Recall |
Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.
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FDA Determined Cause 2 |
Process control |
Action |
Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425.
For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET. |
Quantity in Commerce |
831 screws |
Distribution |
Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = JEY and Original Applicant = WALTER LORENZ SURGICAL, INC.
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