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 |
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