Recall Z-1462-2018 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
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.
| Date | Jan 30, 2018 |
| Status | Terminated |
| Reason | Customers may receive the incorrect size implant from what is labeled on the box. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS Stryker Orthopaedics, Aug 5, 2014 |