Date Initiated by Firm | June 09, 2015 |
Date Posted | August 24, 2015 |
Recall Status1 |
Terminated 3 on September 28, 2015 |
Recall Number | Z-2454-2015 |
Recall Event ID |
71470 |
Product Classification |
Guide, surgical, instrument - Product Code FZX
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Product | Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022
Product Usage:
The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems |
Code Information |
Lot Numbers: MM0314R, VA0713, Z1111 |
Recalling Firm/ Manufacturer |
Omnilife Science Inc. 50 Oconnell Way Ste 10 East Taunton MA 02718-1394
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For Additional Information Contact | Matthew Nowland 774-226-1841 |
Manufacturer Reason for Recall | The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. |
FDA Determined Cause 2 | Device Design |
Action | Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390. |
Quantity in Commerce | 15 |
Distribution | Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia. |
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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