Recall Z-0811-2020— Howmedica Osteonics Corp.

Name: FDA recall Z-0811-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-07

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2019-11-07, terminated 2020-08-31. It names one FDA 510(k) clearance: K974685. Product: Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254. Reason: May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2019-11-07
Terminated: 2020-08-31
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K974685 — OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSOsteonics Corp.·cleared 1998-09-22

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

Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

Reason for recall

May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

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