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.
Reported: August 24, 2016 Initiated: May 23, 2016 #Z-2582-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 182 units
- Distribution
- 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.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Synthes (USA) Products LLC. Units affected: 182 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2582-2016.
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