"***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.
This recall has been terminated (originally issued July 22, 2011).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- May 17, 2010
- Posted
- July 22, 2011
- Terminated
- October 12, 2011
- Recall Number
- Z-2873-2011
- Quantity
- 927
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.
Lot / Code Info
Lot 173770
Root Cause
Labeling mix-ups
Action Taken
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.