Device Recall Titanium Single Vector Distractor Body and Proximal Foot Plate

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 #487.964, Lot # A4JV280; 4038562; 4091232; 4095219; 4454474; 4485940; 4538241; 5021030; 5041163; 5051836; 5140379; 5175699; 5292906; 5321397; 5321398; 5321399; 5332085; 5391292; 5505143; 5505144; 5505147; 5559642; 5559649; 5559854; 5559855; 5559856; 5621111; 5621115; 5621126; 5621127; 5621128; 5621130; 5868674; 6250788; 6250789; 6250793; 6397763; 6538895; 6551653; 6720328; 6932326; 7489023; 7489024; 7609552; A4JY067, Mfg date 17MAY1999 - 04SEP2014, Exp. date 22MAR2020-04SEP2034

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/30mm; Catalog ID 487.964 || 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 # 487.965, Lot # A4JV312; 3959731; 3988317; 4038563; 4091229; 4095071; 4375627; 4375628; 4375629; 4407383; 4420112; 4435710; 4664397; 4664398; 4746860; 5021031; 5143278; 5175697; 5282148; 5321401; 5321402; 5321404; 5332086; 5332087; 5391281; 5391293; 5505151; 5505153; 5559857; 5559858; 5559859; 5621131; 5621132; 5621145; 5621150; 5621166; 5841367; 5857578; 5859707; 5859708; 5859710; 5859711; 6130707; 6130708; 6287524; 6287525; 6538904; 6551654; 6720329; 7458399; 7865439; 9916673; A4JX605, mfg. date 14MAY1999 - 27APR2016, exp. date 24SEP2019-27APR2036

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/30mm; Catalog ID 487.965 || 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 # 487.974, Lot# A4JY041; 3949739; 4038565; 4044599; 4091233; 4600267; 4744818; 4745317; 4873173; 4873174; 5202231; 5202232; 5202233; 5202234; 5298113; 5304974; 5354033; 5469087; 5820678; 5860826; 6044556; 6199927; 6778533; 6877042; 6983832; 7492522; 7880980; 7931712; 9885355, mfg. date 11JUN1999 -21DEC2015, exp. date 20JUL2019-21DEC2035

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 Proximal Foot/Right; Catalog ID 487.974 || 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 #487.975, Lot# A4JV281; 3959732; 3959733; 4038566; 4044600; 4095085; 4418691; 4479352; 4597089; 4767010; 4851967; 4851968; 5277361; 5346057; 5419963; 5433149; 5445352; 5445632; 5445638; 5785469; 5785471; 5828442; 5828447; 5847302; 5847357; 5883452; 6107608; 6107609; 6107614; 6107615; 6141641; 6141642; 6164420; 6164421; 6819614; 7489031; 7537257; 7865426; 7935481; A4JY058, mfg. date 14MAY1999 - 22APR2015, exp. date 06OCT2019-22APR2035

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 Proximal Foot/Left; Catalog ID 487.975 || 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.