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.
FDA Recall Z-1462-2018 · Posted None
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Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2018-01-30
Date Terminated2020-05-07
Product Quantity77 total products
Reason for Recall
Customers may receive the incorrect size implant from what is labeled on the box.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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