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U.S. Department of Health and Human Services

Class 3 Device Recall Cross Drive Screw

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  Class 3 Device Recall Cross Drive Screw see related information
Date Initiated by Firm November 08, 2010
Date Posted January 23, 2012
Recall Status1 Terminated 3 on January 31, 2012
Recall Number Z-0835-2012
Recall Event ID 59181
510(K)Number K953385  
Product Classification Screw, fixation, bone, non-spinal, metallic - Product Code NDJ
Product Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***"

"***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***"

Products subject to recall:
REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120.

REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120.

Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Code Information Lot # 622120
Recalling Firm/
Manufacturer		 Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Christy Cain
904-741-9498
Manufacturer Reason
for Recall		 On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Biomet Microfixation, Jacksonville, FL, sent an Urgent Medical Device Safety Alert letter dated November 8, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX to 904-741-9425. If consignees further distributed this product, they must notify the recipient of this action by providing the recipient a copy of the notice. For questions call 800-874-7711 or 904-741-4400, ext 468.
Quantity in Commerce 295
Distribution Worldwide Distribution - USA including CA, GA, OH, TX, and VA and the countries of S Africa and Japan
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.
510(K) Database 510(K)s with Product Code = NDJ and Original Applicant = WALTER LORENZ SURGICAL, INC.
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