CLASS II ONGOING Device recall · Reported 3 Jan 2024 · FDA Enforcement Report

RibLoc U Plus 90 Instrument Primary Guide Assy, Low Profile recalled

Acumed is recalling RibLoc U Plus 90 Instrument Primary Guide Assy, Low Profile, distributed nationwide in the US. The recall was initiated on 27 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled513 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0618-2024
FDA event ID: 93470
Recalling firm: Acumed, Hillsboro, OR
Classification: Class II
Status: Ongoing
Recall initiated: 27 Nov 2023
FDA classified: 26 Dec 2023
Reported: 3 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Nov 2023	Recall initiated by company
26 Dec 2023	Classified by FDA	+29 days
3 Jan 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to potential breakage during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, NJ, OH, OR, SC, TX, UT, VA, WA, and WI. The country of Australia.

Nationwide Alabama Arizona California Colorado Florida Georgia Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina New Jersey Ohio Oregon

Questions about this recall

Why was it recalled?

Due to potential breakage during use.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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