FDAFDA · Food and drugs·Recall number Z-2057-2013
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Published September 4, 2013 · Recall initiated: May 31, 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
The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
- Lot
- Part number J8301-F
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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