RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an
Summary
The FDA issued a Class II for RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The R by Acumed LLC. Reason: Due to potential breakage during use..
Details
Source
Device Recall
External ID
Z-0618-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 513 units
Reason for Recall
Due to potential breakage during use.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-27
Company
Hillsboro, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 94 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Acumed LLC has 17 FDA actions in our database, including 8 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Acumed LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Acumed LLC have FDA actions?
Acumed LLC has 17 FDA actions in our database, including 8 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0618-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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