Recall Z-0875-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0875-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-21

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-01-21, terminated 2017-06-08. It names one FDA 510(k) clearance: K123604. Product: Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.. Reason: During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Terminated: 2017-06-08
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123604 — ABG III MONOLITHIC HIP STEMHowmedica Osteonics Corp.·cleared 2013-08-16

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, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.

Reason for recall

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

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