Recall Z-2105-2023— Wright Medical Technology, Inc.

Name: FDA recall Z-2105-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-13

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2023-06-13. It names one FDA 510(k) clearance: K123954. Product: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.. Reason: The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-13
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 Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Reason for recall

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

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