Recall Z-2264-2021— Biomet, Inc.

Name: FDA recall Z-2264-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-02

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2021-06-02, terminated 2022-07-06. It names one FDA 510(k) clearance: K090757. Product: Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312. Reason: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-06-02
Terminated: 2022-07-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K090757 — BIOMET MODULAR FEMORAL REVISION SYSTEMBiomet, Inc.·cleared 2009-09-25

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

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312

Reason for recall

Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

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