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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Revision Knee

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  Class 2 Device Recall Triathlon Revision Knee see related information
Date Initiated by Firm January 12, 2018
Create Date April 24, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-1512-2018
Recall Event ID 79661
510(K)Number K141056  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Knee Prosthesis, Sterile, Single-Use devices

Product Usage:
The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Code Information Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact
201-831-5000
Manufacturer Reason
for Recall		 Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
FDA Determined
Cause 2		 Error in labeling
Action Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified.
Quantity in Commerce 6 units of catalog 5521-B-400
Distribution Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
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 = MBH and Original Applicant = STRYKER ORTHOPAEDICS
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