Recall Z-2329-2021— Howmedica Osteonics Corp.

Name: FDA recall Z-2329-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-01

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2021-07-01, terminated 2023-05-17. It names one FDA 510(k) clearance: K141056. Product: Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700. Reason: 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..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Terminated: 2023-05-17
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker Orthopaedics·cleared 2014-08-05

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

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.