Recall Z-0618-2024— Acumed LLC
Class II · Ongoing
Class II FDA medical device recall by Acumed LLC, initiated 2023-11-27. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to potential breakage during use..
- Recalling firm
- Acumed LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-27
- Firm location
- Hillsboro, OR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.