Z-1382-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 5, 2013
- Initiation Date
- February 20, 2013
- Termination Date
- March 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femoral head, ¿32mm, +0mm Femoral head, ¿32mm, +5mm Femoral head, ¿32mm, +10mm Femoral head, ¿36mm, -3mm Femoral head, ¿36mm, +0mm Femoral head, ¿36mm, +5mm Femoral head, ¿36mm, +10mm Variety of hip and knee implants and instruments, multiple uses.
Reason for Recall
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Distribution Pattern
Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Code Information
Item No. 1201-1126 1201-1326 1201-1526 1201-1726 1201-1028 1201-1128 1201-1428 1201-1828 1201-1032 1201-1132 1201-1432 1201-1832 1201-1036 1201-1136 1201-1436 1201-1836