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Class 2 Device Recall THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM |
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Date Initiated by Firm |
May 17, 2010 |
Date Posted |
July 22, 2011 |
Recall Status1 |
Terminated 3 on October 12, 2011 |
Recall Number |
Z-2873-2011 |
Recall Event ID |
59002 |
510(K)Number |
K953385
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Product Classification |
Screw, fixation, bone - Product Code HWC
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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.
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Code Information |
Lot 173770 |
Recalling Firm/ Manufacturer |
Biomet Microfixation, Inc. 1520 Tradeport Dr Jacksonville FL 32218-2480
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For Additional Information Contact |
Laura Sabo 904-741-4400
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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.
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FDA Determined Cause 2 |
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
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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 = HWC and Original Applicant = WALTER LORENZ SURGICAL, INC.
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