Clarus Medical, Llc Recall 88399
Description: Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Clarus Medical, Llc Recall 88399 Information
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2405-2021 |
Event ID | 88399 |
Event Description | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 |
Product Type | Devices |
Distribution | Distribution in US - 18 accounts 1 foreign account |
Quantity | 858 units |
Recall Reason | The sterile barrier seal may be compromised. |
Device Classification | 20210908 |
Device Code Info | Model Numbers 1100-002 and 1100-002 SHORT; Serial Numbers 64139 through 65022 |
Center Classification Date | 20210902 |
Recall Initiation Date | 20210727 |
Recalling Firm | Clarus Medical, Llc |
Initial Notification | Letter |
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