"***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.
Recall
- Recall Number
- Z-2873-2011
- Event Number
- 59002
- Firm
- Biomet Microfixation, Inc.
- FEI Number
- 1032347
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- May 17, 2010
- Posted
- July 22, 2011
- Terminated
- October 12, 2011
- Address
- 1520 Tradeport Dr, Jacksonville, FL, 32218-2480
Description
"***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.
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.
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.
Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.
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