Recall Z-0870-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0870-2016
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: K123401. Product: Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread 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

K123401 — GAMMA3 AND T2 RECON TARGETING DEVICESStryker Trauma AG·cleared 2013-01-23

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, Gamma K-Wire 3.2x450 mm, UNS-Thread 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.