| Class 2 Device Recall Femoral component | |
Date Initiated by Firm | February 20, 2013 |
Date Posted | May 24, 2013 |
Recall Status1 |
Terminated 3 on March 26, 2014 |
Recall Number | Z-1378-2013 |
Recall Event ID |
64588 |
510(K)Number | K120507 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Femoral component, CR, cemented, #1, left 2103-1310
Femoral component, CR, cemented, #2, left 2103-1320
Femoral component, CR, cemented, #3, left 2103-1330
Femoral component, CR, cemented, #4, left 2103-1340
Femoral component, CR, cemented, #5, left 2103-1350
Femoral component, CR, cemented, #6, left 2103-1360
Femoral component, CR, cemented, #1, right 2103-1410
Femoral component, CR, cemented, #2, right 2103-1420
Femoral component, CR, cemented, #3, right 2103-1430
Femoral component, CR, cemented, #4, right 2103-1440
Femoral component, CR, cemented, #5, right 2103-1450
Femoral component, CR, cemented, #6, right 2103-1460
Femoral component, PS, #1, left 2103-3110
Femoral component, PS, #2, left 2103-3120
Femoral component, PS, #3, left 2103-3130
Femoral component, PS, #4, left 2103-3140
Femoral component, PS, #5, left 2103-3150
Femoral component, PS, #6, left 2103-3160
Femoral component,PS, #1, right 2103-3210
Femoral component,PS, #2, right 2103-3220
Femoral component,PS, #3, right 2103-3230
Femoral component,PS, #4, right 2103-3240
Femoral component,PS, #5, right 2103-3250
Femoral component,PS, #6, right 2103-3260
Variety of hip and knee implants and instruments, multiple uses. |
Code Information |
Catalog No. 2103-1310 2103-1320 2103-1330 2103-1340 2103-1350 2103-1360 2103-1410 2103-1420 2103-1430 2103-1440 2103-1450 2103-1460 2103-3110 2103-3120 2103-3130 2103-3140 2103-3150 2103-3160 2103-3210 2103-3220 2103-3230 2103-3240 2103-3250 2103-3260 |
Recalling Firm/ Manufacturer |
Orthopedic Alliance LLC 26157 Jefferson Ave Murrieta CA 92562-9561
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For Additional Information Contact | 909-304-9001 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 136 units |
Distribution | Nationwide Distribution including the states of CA, MD, TX, NV, and WI. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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