Howmedica Osteonics Corp. Recall 87350
Description: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Howmedica Osteonics Corp. Recall 87350 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1186-2021 |
Event ID | 87350 |
Event Description | Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. |
Product Type | Devices |
Distribution | Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV. |
Quantity | 11 devices |
Recall 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. |
Device Classification | 20210317 |
Device Code Info | Catalogue # 5536-B-400, Lot Number CTD44301 |
Center Classification Date | 20210308 |
Recall Initiation Date | 20210210 |
Recalling Firm | Howmedica Osteonics Corp. |
Initial Notification | Letter |
Similar To |