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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 Kneesee related information
Date Initiated by FirmJanuary 12, 2018
Create DateApril 24, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall NumberZ-1512-2018
Recall Event ID 79661
510(K)NumberK141056 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
ProductKnee 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
ActionBranches/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 Commerce6 units of catalog 5521-B-400
DistributionAffected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MBH
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