Recall Z-2873-2011 ยท HWC Screw, Fixation, Bone
Biomet Microfixation, Inc.
"***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.
| Date | Jul 22, 2011 (initiated May 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 927 |
| Distribution | Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc., Sep 28, 1995 |