FDA-Device2016-08-24Class II
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.
Synthes (USA) Products LLC
Hazard
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
Sold states
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.
Affected count
259 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2584-2016Don't want to check this manually?
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