Device product
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.
Z-2586-2016
Product summary
- Event
- Event 74419
- Status
- Terminated
- Classification
- Class II
- Quantity
- 599 units
- Official record key
device-enforcement:Z-2586-2016
Official wording
Reason: 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.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.