FDA recall Z-0618-2024

Acumed LLC · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2023-11-27
Report date
2024-01-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hillsboro, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0618-2024