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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 30, 2018
Create Date April 20, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-1462-2018
Recall Event ID 79600
510(K)Number K141056  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601

The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Code Information Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A 
Recalling Firm/
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Eric Petschler
Manufacturer Reason
for Recall
Customers may receive the incorrect size implant from what is labeled on the box.
FDA Determined
Cause 2
Under Investigation by firm
Action On January 31, 2018 branches/agencies received notification of the recall via e-mail and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to branches, agencies & hospital risk management via UPS (with return receipt) on January 31, 2018 with an expected arrival date of February 02, 2018. Customers were asked to complete a Notification Business Reply Form and return via e-mail or fax. Affected product is to be returned to the manufacturer. Customers with questions may contact (201)831-6693.
Quantity in Commerce 77 total products
Distribution USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
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