Recall Z-0393-2022— Wright Medical Technology Inc

Name: FDA recall Z-0393-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-03

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology Inc, initiated 2021-12-03. It names one FDA 510(k) clearance: K061808. Product: Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.. Reason: The incorrect product is contained in the packaging..

Recalling firm: Wright Medical Technology Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-12-03
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K061808 — DARCO LOCKING BONE PLATE SYSTEMDarco International, Inc.·cleared 2006-08-17

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 DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

Reason for recall

The incorrect product is contained in the packaging.

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