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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 Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 Tibial baseplate,cemented,#3 2203-3030 Tibial baseplate,cemented,#4 2203-3040 Tibial baseplate, cemented, #5 2203-3050 Tibial baseplate, cemented, #6 2203-3060 Tibial insert,CR,plained,#1,9mm 2303-1211 Tibial insert,CR,plained,#1,11mm 2303-1212 Tibial insert,CR,plained,#1,13mm 2303-1213 Tibial insert,CR,plained,#1,15mm 2303-1214 Tibial insert,CR,plained,#1,18mm 2303-1215 Tibial insert,CR,plained,#2,9mm 2303-1221 Tibial insert,CR,plained,#2,11mm 2303-1222 Tibial insert,CR,plained,#2,13mm 2303-1223 Tibial insert,CR,plained,#2,15mm 2303-1224 Tibial insert,CR,plained,#2,18mm 2303-1225 Tibial insert,CR,plained,#3,9mm 2303-1231 Tibial insert,CR,plained,#3,11mm 2303-1232 Tibial insert,CR,plained,#3,13mm 2303-1233 Tibial insert,CR,plained,#3,15mm 2303-1234 Tibial insert,CR,plained,#3,18mm 2303-1235 Tibial insert,CR,plained,#4,9mm 2303-1241 Tibial insert,CR,plained,#4,11mm 2303-1242 Tibial insert,CR,plained,#4,13mm 2303-1243 Tibial insert,CR,plained,#4,15mm 2303-1244 Tibial insert,CR,plained,#4,18mm 2303-1245 Tibial insert,CR,plained,#5,9mm 2303-1251 Tibial insert,CR,plained,#5,11mm 2303-1252 Tibial insert,CR,plained,#5,13mm 2303-1253 Tibial insert,CR,plained,#5,15mm 2303-1254 Tibial insert,CR,plained,#5,18mm 2303-1255 Tibial insert,CR,plained,#6,9mm 2303-1261 Tibial insert,CR,plained,#6,11mm 2303-1262 Tibial insert,CR,plained,#6,13mm 2303-1263 Tibial insert,CR,plained,#6,15mm 2303-1264 Tibial insert,CR,plained,#6,18mm 2303-1265 Tibial insert, PS , #1, 9mm 2303-3011 Tibial insert, PS , #1, 11mm 2303-3012 Tibial insert, PS , #1, 13mm 2303-3013 Tibial insert, PS , #1, 15mm 2303-3014 Tibial insert, PS , #1, 18mm 2303-3015 Tibial insert, PS , #2, 9mm 2303-3021 Tibial insert, PS , #2, 11mm 2303-3022 Tibial insert, PS , #2, 13mm 2303-3023 Tibial insert, PS , #2, 15mm 2303-3024 Tibial insert, PS , #2, 18mm 2303-3025 Tibial insert, PS , #3, 9mm 2303-3031 Tibial insert, PS , #3, 11mm 2303-3032 Tibial insert, PS , #3, 13mm 2303-3033 Tibial insert, PS , #3, 15mm 2303-3034 Tibial insert, PS , #3, 18mm 2303-3035 Tibial insert, PS , #4, 9mm 2303-3041 Tibial insert, PS , #4, 11mm 2303-3042 Tibial insert, PS , #4, 13mm 2303-3043 Tibial insert, PS , #4, 15mm 2303-3044 Tibial insert, PS , #4, 18mm 2303-3045 Tibial insert, PS , #5, 9mm 2303-3051 Tibial insert, PS , #5, 11mm 2303-3052 Tibial insert, PS , #5, 13mm 2303-3053 Tibial insert, PS , #5, 15mm 2303-3054 Tibial insert, PS , #5, 18mm 2303-3055 Tibial insert, PS , #6, 9mm 2303-3061 Tibial insert, PS , #6, 11mm 2303-3062 Tibial insert, PS , #6, 13mm 2303-3063 Tibial insert, PS , #6, 15mm 2303-3064 Tibial insert, PS , #6, 18mm 2303-3065 Variety of hip and knee implants and instruments, multiple uses.
Recall Number Z-1379-2013
Classification Class II
Code Info Catalog No. 2203-3010 2203-3020 2203-3030 2203-3040 2203-3050 2203-3060 2303-1211 2303-1212 2303-1213 2303-1214 2303-1215 2303-1221 2303-1222 2303-1223 2303-1224 2303-1225 2303-1231 2303-1232 2303-1233 2303-1234 2303-1235 2303-1241 2303-1242 2303-1243 2303-1244 2303-1245 2303-1251 2303-1252 2303-1253 2303-1254 2303-1255 2303-1261 2303-1262 2303-1263 2303-1264 2303-1265 2303-3011 2303-3012 2303-3013 2303-3014 2303-3015 2303-3021 2303-3022 2303-3023 2303-3024 2303-3025 2303-3031 2303-3032 2303-3033 2303-3034 2303-3035 2303-3041 2303-3042 2303-3043 2303-3044 2303-3045 2303-3051 2303-3052 2303-3053 2303-3054 2303-3055 2303-3061 2303-3062 2303-3063 2303-3064 2303-3065
Product Distributed Qty 459 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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