Date Initiated by Firm | July 11, 2014 |
Date Posted | August 17, 2014 |
Recall Status1 |
Terminated 3 on October 06, 2014 |
Recall Number | Z-2257-2014 |
Recall Event ID |
68898 |
510(K)Number | K060569 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY
Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed |
Code Information |
CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666 |
Recalling Firm/ Manufacturer |
Ortho Development Corporation 12187 Business Park Dr Draper UT 84020-8663
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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 | 1 |
Distribution | Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. |
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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