FDA Device recall Z-0521-2020
ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement by Zimmer Biomet, citing elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0521-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
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.
Identifiers
| code_info | 662230 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.