RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY — Class II medical device recall Z-0618-2024

Ongoing recall by Acumed LLC, reported 2024-01-03, distributed nationwide. Due to potential breakage during use.

Recall number	`Z-0618-2024`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Acumed LLC, Hillsboro, OR, United States
Recall initiated	2023-11-27
Classified	2023-12-26
Reported by FDA	2024-01-03
Distributed	Nationwide (US)
Countries outside the US	AU
Quantity	513 units
Reason classes	device malfunction
Lot numbers	`10806378118210-538351000000`, `10806378118210-538352000000`, `10806378118210-544036000000`, `10806378118210-554505000000`, `10806378118210-L1810012181031`, `10806378118210-L1902009190207`, `10806378118210-L1909017190918`, `10806378118210-L2001005200130`, `10806378118210-L2005002200504`, `10806378118210-L2010046000000`, `10806378118210-L2010048000000`, `538351`, `538352`, `544036`, `554505`, `L1810012`, `L1902009`, `L1909017`, `L2001005`, `L2005002`, `L2010046`, `L2010048`
Model numbers	`RBL2320`

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 for recall

Due to potential breakage during use.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0618-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.