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.
Enforcement
- Recall Number
- Z-2586-2016
- Event ID
- 74419
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 24, 2016
- Initiation Date
- May 23, 2016
- Classification Date
- August 17, 2016
- Termination Date
- December 13, 2016
- Address
- 1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States
Description
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.
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.
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
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.
599 units