Recall Z-2329-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
| Date | Jul 1, 2021 |
| Status | Terminated |
| Reason | The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate. |
| Root cause | Under Investigation by firm |
| Action | On July 1, 2021, the firm notified customers via Urgent Medical Device Recall. The letter listed the hazards and harms potentially associated with the recalled product and also listed mitigation factors. Patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. It should be noted that the failure of the insert to fully seat, may not be evident on x-ray unless the insert has dislodged. Actions Needed: Our records indicate that |
| Quantity | 14 US; 2 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy. |
| 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 |