Recall Z-1186-2021 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
| Date | Feb 10, 2021 |
| Status | Terminated |
| Reason | Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate. |
| Root cause | Under Investigation by firm |
| Action | On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. |
| Quantity | 11 devices |
| Distribution | Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV. |
| FDA record | Open on fda.gov |