FDA Recall Terminated

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: Z-1379-2013 · Initiated February 20, 2013

Recall

Recall Number: Z-1379-2013
Event Number: 64588
Firm: Orthopedic Alliance LLC
FEI Number: 3004022256
Product Code: JWH
Status: Terminated
Root Cause: Labeling design
Initiated: February 20, 2013
Posted: May 24, 2013
Terminated: March 26, 2014
Address: 26157 Jefferson Ave, Murrieta, CA, 92562-9561

Description

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.

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.

Distribution

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

Quantity

459 units