Recall Z-0881-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0881-2016
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. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm 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

Product description

Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm 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.