FDA Device recall Z-0301-2018
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
- FDA Device
- Class II
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class II recall of CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 by Zimmer Biomet, citing possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0301-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-05 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Reason
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
Identifiers
| code_info | Lot Number: 854540 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0301-2018%22
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