Triathlon Knee System Posterior Stabilized Components

• • Ongoing Z-0023-2025 FDA Class II ·initiated 4 Sep 2024 ·on shared 510(k) K141056

  Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.

• • Terminated Z-2329-2021 FDA Class II ·initiated 1 Jul 2021 ·on shared 510(k) K141056

  The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

• • Terminated Z-1186-2021 FDA Class II ·initiated 10 Feb 2021

  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.

• 4 recalls, same reason

  • Terminated Z-2757-2019 FDA Class II ·initiated 19 Aug 2019
  • Terminated Z-2760-2019 FDA Class II ·initiated 19 Aug 2019
  • Terminated Z-2759-2019 FDA Class II ·initiated 19 Aug 2019
  • Terminated Z-2758-2019 FDA Class II ·initiated 19 Aug 2019

  Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

• • Terminated Z-1462-2018 FDA Class II ·initiated 30 Jan 2018

  Customers may receive the incorrect size implant from what is labeled on the box.

• • Terminated Z-1512-2018 FDA Class II ·initiated 12 Jan 2018

  Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

• • Terminated Z-2389-2015 FDA Class II ·initiated 29 May 2015

  Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).

• • Terminated Z-2360-2015 FDA Class II ·initiated 29 May 2015 ·on shared 510(k) K141056

  Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K141056 ↗

FDA Product Code

MBH

Device Class

Class II

Regulation

21 CFR Part 888.3565

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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