Recall Z-1186-2021— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2021-02-10, terminated 2023-05-30. It names 2 FDA 510(k) clearances: K141056, K123486. 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..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-10
- Terminated
- 2023-05-30
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS
- K123486 — TRIATHLON TRITANIUM TIBIAL BASEPLATE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.