Z-2843-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- July 27, 2016
- Termination Date
- March 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41
Product Description
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Reason for Recall
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Distribution Pattern
Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
Code Information
Product Number: 00-1050-3214 Lot Number: NM02341 Product Number: 00-1050-3214 Lot Number: NM02342