Recall Z-1466-2023— Wright Medical Technology, Inc.

Name: FDA recall Z-1466-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-10

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2023-04-10. It names one FDA 510(k) clearance: K120359. Product: stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation. Reason: Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-10
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K120359 — ORTHOLOC 3DI HALLUX SYSTEMWrightmedicaltechnologyinc·cleared 2012-05-03

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 ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

Reason for recall

Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

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