| Class 2 Device Recall THINFLAP SYSTEM CROSSDRIVE, SELFDRILLING SCREW 1.5X4MM (.059X.159") (WXL)TITANIUM |  |
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 |
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 FL 32218-2480
|
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 | 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 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 = HWC
|
|
|
|