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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Acumed LLC: RibLoc U Plus 90 Low Profile Primary Guide Recalled for Potential Breakage

Agency Publication Date: December 26, 2023
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Summary

Acumed LLC is recalling approximately 513 units of the RibLoc U Plus 90 Instrument Primary Guide (Low Profile), model RBL2320. This specialized surgical instrument is used with power systems to compress rib plates onto bone and guide the drilling and installation of screws. The recall was initiated because the instrument may break during use, which could lead to surgical delays or the potential for metal fragments to remain in a patient.

Risk

If the instrument breaks during a procedure, it could result in surgical complications, prolonged anesthesia time, or the risk of small metal fragments being left in the surgical site. No specific injuries have been reported in the provided data, but the mechanical failure poses a direct risk to patient safety during rib stabilization surgeries.

What You Should Do

  1. Identify your equipment by checking for the RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE (Ref: RBL2320).
  2. Verify if your device matches one of the following Batch/Lot numbers: 538351, 538352, 544036, 554505, L1810012, L1902009, L1909017, L2001005, L2005002, L2010046, or L2010048.
  3. Check for UDI codes including 10806378118210-538351000000, 10806378118210-538352000000, 10806378118210-544036000000, 10806378118210-554505000000, 10806378118210-L1810012181031, 10806378118210-L1902009190207, 10806378118210-L1909017190918, 10806378118210-L2001005200130, 10806378118210-L2005002200504, 10806378118210-L2010046000000, and 10806378118210-L2010048000000.
  4. Immediately contact your healthcare provider or Acumed LLC at their Hillsboro, Oregon headquarters to receive further instructions regarding affected instruments.
  5. For additional questions or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320
Model / REF:
RBL2320
UPC Codes:
10806378118210
Lot Numbers:
538351
538352
544036
554505
L1810012
L1902009
L1909017
L2001005
L2005002
L2010046
L2010048

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93470
Status: Active
Manufacturer: Acumed LLC
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 513 units
Distributed To: Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.