—#162748

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.

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K141056
Affected lot / code info: Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A

Why it was recalled

Customers may receive the incorrect size implant from what is labeled on the box.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

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

Timeline

Recall initiated: 2018-01-30
Terminated: 2020-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162748. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.