FDA Device recall Z-1186-2021
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer by Howmedica Osteonics, citing 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 Num….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1186-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-10 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Howmedica Osteonics |
| Distribution | AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV |
Product
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
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.
Identifiers
| code_info | Catalogue # 5536-B-400, Lot Number CTD44301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1186-2021%22
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