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U.S. Department of Health and Human Services

Class 2 Device Recall Pivot Bipolar Cup

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  Class 2 Device Recall Pivot Bipolar Cup see related information
Date Initiated by Firm July 11, 2014
Date Posted August 17, 2014
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-2253-2014
Recall Event ID 68898
510(K)Number K050966  
Product Classification Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
Product Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY

Product Usage:
Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
Code Information Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot A136263,Pivot Bipolar Cup 22x50mm,Part 133-2250,Lot A136265,Pivot Bipolar Cup 22x51mm,Part 133-2251,Lot A136266,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136269,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136268,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136267,Pivot Bipolar Cup 22x53mm,Part 133-2253,Lot A136270,
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 Business Park Dr
Draper UT 84020-8663
For Additional Information Contact Mike Ensign
801-553-9991
Manufacturer Reason
for Recall		 Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
FDA Determined
Cause 2		 Packaging process control
Action Ortho Development notified all affected consignees/distributors of the recall via email on July 11, 2014 which included a list of the affected product (part numbers, lot numbers and quantities) under their control. An RMA number and return shipping label were also included with the email. Emails were followed up with phone calls to verify receipt of the notification.
Quantity in Commerce 188
Distribution Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
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 = KWY and Original Applicant = ORTHO DEVELOPMENT CORP.
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