Device Recall TITAN

Part # 04.004.000, lot # 7950994

Orthopedic Devices

2

Yes

US Distribution to states of: MO and SC.

TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

Item: UNIHT

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Titanium Hexed Uniscrew || Dental implants

Item: UNIST

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Titanium Square Uniscrew || Dental implants

Part # 487.962, Lot # A4JY080; 4042146; 4042147; 4365410; 4548558; 4664392; 5041113; 5041114; 5041162; 5071337; 5229307; 5414447; 5414448; 5414449; 5422905; 5621082; 5621083; 5621088; 5696010; 6164423; 6164425; 6164555; 6171239; 6171240; 6397761; 7537258; 7927945, mfg date 09JUN1999 -30JUN2015, exp date 22MAR2020-30JUN2035

Dental Devices

2

Yes

Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.

TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 || The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

Part #487.963, Lot # A4JX956; 4038561; 4091230; 4281408; 4294703; 4454536; 4475459; 5041111; 5041112; 5414450; 5414451; 5505099; 5505140; 5621104; 5621108; 5621109; 5621110; 6291848; 6879052; 7626782; 7865438; 9890200; mfg. 09JUN1999 -26APR2016, Exp. 22MAR2020-26APR2036

Dental Devices

2

Yes

Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 || The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.