Device Recall Stableloc (TM) External Fixation System

Part number (REF): FX-4001-S; Lot numbers (Work order #): W53416, W53682, W53683, and W53684.

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA, including states of VA, NC, FL, ME, WA, GA, TX and PA and countries of Spain, Japan and Greece.

Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"