Recall Z-2582-2016— Synthes (USA) Products LLC

Name: FDA recall Z-2582-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-23

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-05-23, terminated 2016-12-13. It names one FDA 510(k) clearance: K981075. Product: 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: 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..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Terminated: 2016-12-13
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K981075 — SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEETSynthes (Usa)·cleared 1998-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.