Orthopedic Alliance LLC: 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, 10hooded,44mm U2 Acetabular cup liner assembly, 10hooded,46mm U2 Acetabular cup liner assembly, 10hooded,48mm U2 Acetabular cup liner assembly, 10hooded,50mm U2 Acetabular cup liner assembly, 10hooded,52mm U2 Acetabular cup liner assembly, 10hooded,54mm U2 Acetabular cup liner assembly, 10hooded,56mm U2 Acetabular cup liner assembly, 10hooded,58mm U2 Acetabular cup liner assembly, 10hooded,60mm U2 Acetabular cup liner assembly, 10hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

Recall number

Z-1381-2013

Recalling firm

Orthopedic Alliance LLC

Product

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, 10hooded,44mm U2 Acetabular cup liner assembly, 10hooded,46mm U2 Acetabular cup liner assembly, 10hooded,48mm U2 Acetabular cup liner assembly, 10hooded,50mm U2 Acetabular cup liner assembly, 10hooded,52mm U2 Acetabular cup liner assembly, 10hooded,54mm U2 Acetabular cup liner assembly, 10hooded,56mm U2 Acetabular cup liner assembly, 10hooded,58mm U2 Acetabular cup liner assembly, 10hooded,60mm U2 Acetabular cup liner assembly, 10hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

Status

Terminated

Initiated

2013-02-20

Posted

2013-05-24

Terminated

2014-03-26

Reason

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.

Root cause

Labeling design

Action

A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Quantity

30 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K121777"]

PMA numbers

not on file

Product code

LPH

Firm FEI

3004022256

Firm city

Murrieta

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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