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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral component

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  Class 2 Device Recall Femoral component see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = UNITED ORTHOPEDIC CORPORATION
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