Lower risk Medical device recall · FDA · Published November 27, 2023

Acumed RibLoc U Plus 90 Primary Guide Recall: Potential Breakage Hazard

Acumed recalls RibLoc U Plus 90 Primary Guide (RBL2320) due to potential breakage during use. Affected units have specific batch numbers. Consumers should contact Acumed for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0618-2024Medical device Acumed ›

Lower-risk recall

Due to potential breakage during use.

Take action

Contact the company

Recalling firmAcumed LLC5885 NW Cornelius Pass Rd · Hillsboro, OR 97124-9370

✎ GovInfoNow plain-language explainer

Acumed is recalling its RibLoc U Plus 90 Primary Guide (RBL2320) instruments because they may break during use. This could lead to complications in surgical procedures if the device fails while being used. Read more at govinfonow.com/recall/56764-acumed-ribloc-u-plus-90-primary-guide-recall-potential-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/56764-acumed-ribloc-u-plus-90-primary-guide-recall-potential-breakage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0618-2024

Cite this page

“Acumed RibLoc U Plus 90 Primary Guide Recall: Potential Breakage Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56764-acumed-ribloc-u-plus-90-primary-guide-recall-potential-breakage. Based on FDA recall #Z-0618-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0618-2024%22&limit=1).

The FDA announced on 2023-11-27 that Acumed LLC is recalling RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 due to potential breakage during use. The agency issued recall number Z-0618-2024 for the Class II device.

How to tell if you have it

Brand: Acumed
Product: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320
Part Number: RBL2320
Lot Codes: 538351, 538352, 544036, 554505, L1810012, L1902009, L1909017, L2001005, L2005002, L2010046, L2010048
Units: 513

The hazard

The RBL2320 Low Profile Primary Guide may break during use. The instrument is used with a power system to compress RibLoc plates onto bone, determine screw length, locate hole positions, and provide proper orientation for screw installation.

Context

GovInfoNow's records show Acumed LLC has 4 other recalls on record since 2022-03-09. Other recent recalls of similar products include Acumed Hexalob Screw Recall: Risk of Breakage During Wrist Fixation (2026-05-28), Acumed LLC - Medical Devices (2023-12-19), and Acumed Dual-Trak Clavicle Screws Recalled: Distribution Without Pre-Market Clearance (2022-11-29). Other recent recalls of similar products include Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall: Plastic Guide Breakage Risk (2026-05-20), Zimmer Off-Axis Alliance Glenoid Reamer Guide Recall: Plastic Guides May Cause Breakage (2026-05-20), and Zimmer Off-Axis Shoulder System Recall: Plastic Guides May Cause Breakage (2026-05-20).

How to tell if you have this one

Check for the model number RBL2320 on the instrument. Affected units have specific batch numbers listed in the recall notice, including UDI codes like 10806378118210-538351000000 through 10806378118210-L2010048000000.

Brand
Acumed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the model number RBL2320 and the specific batch numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 26 states.

FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, North Carolina, Ohio, Oregon, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 37 days after the firm started it.

Nov 27, 2023Firm started the recall
Dec 26, 2023FDA classified it Class II
Jan 3, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/56764-acumed-ribloc-u-plus-90-primary-guide-recall-potential-breakage">Acumed RibLoc U Plus 90 Primary Guide Recall: Potential Breakage Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0618-2024 (November 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0618-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.