FDAClass IIJanuary 3, 2024

RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY recall

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…

Why was RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY recalled?

Due to potential breakage during use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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

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…
Recalling firm
Acumed LLC
Quantity
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.
Recall date
January 3, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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