FDAFDA · Food and drugs·Recall number Z-0390-2014
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.
Published December 4, 2013 · Recall initiated: July 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Canada.
- Lot
- All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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