Recall Z-0533-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0533-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-08-21, terminated 2021-07-21. It names one FDA 510(k) clearance: K043100. Product: BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement. Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Terminated: 2021-07-21
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K043100 — BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTSBiomet, Inc.·cleared 2005-02-17

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

BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

Reason for recall

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

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