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U.S. Department of Health and Human Services

Class 3 Device Recall BIOMET MICROFIXATION SYSTEM BONE SCREW

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 Class 3 Device Recall BIOMET MICROFIXATION SYSTEM BONE SCREWsee related information
Date Initiated by FirmOctober 06, 2009
Date PostedMarch 17, 2010
Recall Status1 Terminated 3 on April 07, 2010
Recall NumberZ-1151-2010
Recall Event ID 54372
510(K)NumberK953385 
Product Classification Plate, bone - Product Code JEY
ProductBIOMET 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.
FEI Number 1032347
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information ContactChristy Cain
904-741-4400
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.
FDA Determined
Cause 2		Process control
ActionBiomet 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 Commerce831 screws
DistributionWorldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JEY
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