Recall Z-1462-2018— Howmedica Osteonics Corp.

Name: FDA recall Z-1462-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-30

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2018-01-30, terminated 2020-05-07. It names one FDA 510(k) clearance: K141056. Product: Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.. Reason: Customers may receive the incorrect size implant from what is labeled on the box..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-01-30
Terminated: 2020-05-07
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 Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.

Reason for recall

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

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