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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 30, 2018
Create DateApril 20, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall NumberZ-1462-2018
Recall Event ID 79600
510(K)NumberK141056 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
ProductTriathlon 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/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactEric Petschler
201-831-6693
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
ActionOn 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 Commerce77 total products
DistributionUSA (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 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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