FDA Device recall Z-0618-2024
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a…
- FDA Device
- Class II
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a… by Acumed, citing due to potential breakage during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0618-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-27 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Acumed |
| Distribution | US |
Product
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.
Reason
Due to potential breakage during use.
Identifiers
| code_info | Part Number: RBL2320 UDI Code / Batch-Lot Number 10806378118210-538351000000 / 538351 10806378118210-538352000000 / 538…Part Number: RBL2320 UDI Code / Batch-Lot Number 10806378118210-538351000000 / 538351 10806378118210-538352000000 / 538352 10806378118210-544036000000 / 544036 10806378118210-554505000000 / 554505 10806378118210-L1810012181031 / L1810012 10806378118210-L1902009190207 / L1902009 10806378118210-L1909017190918 / L1909017 10806378118210-L2001005200130 / L2001005 10806378118210-L2005002200504 / L2005002 10806378118210-L2010046000000 / L2010046 10806378118210-L2010048000000 / L2010048 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2024%22
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