Recall Z-0313-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-0313-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-15

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2021-10-15. It names one FDA 510(k) clearance: K173499. Product: 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028. Reason: XXX.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2021-10-15
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics·cleared 2018-03-19

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

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028

Reason for recall

XXX

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