PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: January 3, 2024 Initiated: November 27, 2023 #Z-0618-2024

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.

Reason for Recall

Due to potential breakage during use.

Details

Recalling Firm
Acumed LLC
Units Affected
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.
Location
Hillsboro, OR

Frequently Asked Questions

What product was recalled?
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.. Recalled by Acumed LLC. Units affected: 513 units.
Why was this product recalled?
Due to potential breakage during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 3, 2024. Severity: Moderate. Recall number: Z-0618-2024.