Recall Z-2380-2020— Stryker GmbH

Name: FDA recall Z-2380-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-07

Class II · Terminated

Class II FDA medical device recall by Stryker GmbH, initiated 2020-05-07, terminated 2023-09-21. It names one FDA 510(k) clearance: K003018. Product: Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.. Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured.

Recalling firm: Stryker GmbH
Classification: Class II
Status: Terminated
Initiated: 2020-05-07
Terminated: 2023-09-21
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K003018 — TITAN TIBIAL NAILHowmedica Osteonics Corp.·cleared 2000-12-15

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 Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

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