Orthopedic Alliance LLC: Medical Device Recall in 2013 - (Recall #: Z-1381-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: February 20, 2013
Date Posted: June 5, 2013
Recall Number: Z-1381-2013
Event ID: 64588
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.

Status: Terminated
Product Quantity: 30 units
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

Distribution Pattern:

Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated