Recall Z-1477-2024— Wright Medical Technology, Inc.

Name: FDA recall Z-1477-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-06

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2024-03-06. It names one FDA 510(k) clearance: K123954. Product: stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty. Reason: Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-06
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123954 — INFINITY TOTAL ANKLE SYSTEMWrightmedicaltechnologyinc·cleared 2013-04-01

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 Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty

Reason for recall

Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

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