Recall Z-2810-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2810-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-25

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-06-25, terminated 2017-08-30. It names one FDA 510(k) clearance: K033716. Product: Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component. Reason: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-06-25
Terminated: 2017-08-30
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K033716 — TRIDENT ACETABULAR SYSTEMHowmedica Osteonics Corp.·cleared 2005-02-10

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

Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component

Reason for recall

it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.

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