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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description U2 Acetabular cup, Ti beads porous coated, È44mm U2 Acetabular cup, Ti beads porous coated, È46mm U2 Acetabular cup, Ti beads porous coated, È48mm U2 Acetabular cup, Ti beads porous coated, È50mm U2 Acetabular cup, Ti beads porous coated, È52mm U2 Acetabular cup, Ti beads porous coated, È54mm U2 Acetabular cup, Ti beads porous coated, È56mm U2 Acetabular cup, Ti beads porous coated, È58mm U2 Acetabular cup, Ti beads porous coated, È60mm U2 Acetabular cup, Ti beads porous coated, È62mm 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.
Recall Number Z-1381-2013
Classification Class II
Code Info 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
Product Distributed Qty 30 units
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.

Event Detail

Event Id 64588
Product Type Devices
Status Ongoing
Recalling Firm Orthopedic Alliance LLC
City Murrieta
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-20
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
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