Recall Z-0521-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-08-21, terminated 2021-07-21. FDA's recall record names no specific 510(k) clearance for this event. Product: ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium 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
Product description
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium 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.