3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- July 22, 2013
- Posted
- November 26, 2013
- Terminated
- August 18, 2016
- Recall Number
- Z-0390-2014
- Quantity
- 40248
- Firm Location
- West Chester, PA
Reason for Recall
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Lot / Code Info
All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
Root Cause
Labeling False and Misleading
Action Taken
Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.
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