Z-1381-2013 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
- 30 units
Product Description
U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm U2 Acetabular cup liner assembly, 10¿hooded,44mm U2 Acetabular cup liner assembly, 10¿hooded,46mm U2 Acetabular cup liner assembly, 10¿hooded,48mm U2 Acetabular cup liner assembly, 10¿hooded,50mm U2 Acetabular cup liner assembly, 10¿hooded,52mm U2 Acetabular cup liner assembly, 10¿hooded,54mm U2 Acetabular cup liner assembly, 10¿hooded,56mm U2 Acetabular cup liner assembly, 10¿hooded,58mm U2 Acetabular cup liner assembly, 10¿hooded,60mm U2 Acetabular cup liner assembly, 10¿hooded,62mm 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. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662