Recall Z-1042-2023— Biomet, Inc.

Name: FDA recall Z-1042-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-29

Class II · Ongoing

Class II FDA medical device recall by Biomet, Inc., initiated 2022-12-29. It names one FDA 510(k) clearance: K113550. Product: (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112. Reason: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left)..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K113550 — VANGUARD COMPLETE KNEE SYSTEMBiomet Manufacturing Corp·cleared 2012-02-29

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

(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112

Reason for recall

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

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