Recall Z-1380-2021— Arthrex, Inc.

Name: FDA recall Z-1380-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-11

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2021-03-11, terminated 2024-10-29. It names one FDA 510(k) clearance: K032187. Product: Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.. Reason: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Terminated: 2024-10-29
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K032187 — ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEMArthrex, Inc.·cleared 2003-09-22

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

Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.

Reason for recall

It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

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