Z-0618-2024Class II

RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary...

Name: Z-0618-2024 RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary...
Creator: Acumed LLC
Published: 2023-11-27
License: https://open.fda.gov/license/

Acumed LLC / initiated 2023-11-27 / Open, Classified

FDA source

Acumed LLC began a 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 power system to... on 2023-11-27. FDA classified it as Class II and gives the reason as "Due to potential breakage during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0618-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-27
Posted: 2023-12-26
Recalling firm: Acumed LLC
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Due to potential breakage during use.
FDA root cause: Unknown/Undetermined by firm
Action: On 11/27/2023, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx and UPS ground to customers informing them that Acumed is initiating a Recall of all field inventory of Part Number RBL2320, Low Profile Primary Guides due to the potential for breakage during use. Customers are instructed to: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1-The RBL2320, Low Profile Primary Guide is often located with the RBL4030 Instrumentation Tray (as shown in Figure 2 above). Locate the RBL4030 tray and remove the RBL2320, Low Profile Primary guide(s) from the tray. Perform a physical count of their inventory of the RBL2320, Low Profile Primary Guides, and identify any inventory of the batch/lot numbers listed in the table above. 2-Remove the RBL2320, Low Profile Primary Guides removed/segregated in step 1, such that they are taken out of service (i.e., quarantined). 3-Record this data (product, batch/lot number, and quantity) on the Outstanding Field Action Survey found at the end of this recall letter (on page 5). If you do not have product to return, you are still required to complete the survey. 4) Return the completed survey via email to [email protected]. 5) If you have RBL2320, Low Profile Primary Guide(s) to return, please contact Ellie Wood via email at [email protected] so that a Return Authorization Number and return instructions can be provided. *Please note, only the RBL2320, Low Profile Primary Guide needs to be returned. 6) If RBL2320, Low Profile Primary Guide product is not returning, please post this Recall Notification Letter on or near the affected products.
Quantity in commerce: 513 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0618-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0618-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-03	2023-12-26

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)