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U.S. Department of Health and Human Services

Class 2 Device Recall THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM

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 Class 2 Recall
THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM
see related information
Date Posted July 22, 2011
Recall Status1 Terminated on October 12, 2011
Recall Number Z-2873-2011
Recall Event ID 59002
Premarket Notification
510(K) Number
K953385 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA*** www.biometmicrofixation.com***QTY 00001***". Internal fixation screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Code Information Lot 173770
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Laura Sabo
904-741-4400
Manufacturer Reason
for Recall
On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Biomet Microfixation notified distributors and customers by letter, email and telephone calls. Distributors and customers were instructed to fill out and return the Inventory Reconciliation sheet, via Fax to 904-741-9425. Distributors were also instructed to notify their customers if the product was distributed further. For questions regarding this recall customers were instructed to call 1-800-874-7711 or 904-741-4400, ext. 468.
Quantity in Commerce 927
Distribution Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = WALTER LORENZ SURGICAL, INC.
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