Acumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage
Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a risk-of-harm product (surgical instrument that could break during clinical use). No illnesses, injuries, or deaths have been reported. Device failure during a surgical procedure could cause patient harm.
Plain-English summary
Acumed LLC is recalling the RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE (Part Number RBL2320), a surgical instrument used in rib fixation procedures. The device is used with a power system to compress RibLoc plates onto 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.
The recall affects 513 units. The FDA classified this recall as Class II due to the potential for the device to break during use. The affected devices were distributed worldwide, including throughout the United States (Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, South Carolina, Texas, Utah, Virginia, Washington, and Wisconsin) and Australia.
Healthcare facilities and surgical teams using affected devices should immediately cease use and contact Acumed LLC for replacement options or guidance. Affected devices can be identified by Part Number RBL2320 and the specific UDI and batch-lot numbers provided in the official recall notice.
The recalled product
- 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…
- Manufacturer
- Acumed LLC
- Hazard
- Affected units
- 513
Distribution
Related recalls
Same manufacturer · Acumed LLC
See all →- HighAcumed Hexalob Screws Recalled for Risk of Fracture During Use
FDA (Devices) · 2026-07-01
- HighBone plates and surgical screws distributed without FDA pre-market clearance
FDA (Devices) · 2024-03-06
- ModerateAcutrak Bone Screws and Fusion Devices Recalled for Lack of FDA Pre-Market Clearance
FDA (Devices) · 2023-01-04
- ModerateAcumed Acutrak 2 Bone Screws Recalled for Distribution Without FDA Clearance
FDA (Devices) · 2023-01-04
- HighDual-Trak Clavicle Screws recalled: distributed without FDA pre-market clearance
FDA (Devices) · 2023-01-04
Same hazard · device breakage
See all →- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01
Similar recalls
- HighACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk
FDA (Devices) · 2014-02-05
- ModerateIntegra Recalls 2.7mm Drilling Guides Due to Breakage During Use
FDA (Devices) · 2012-09-26
- HighAcumed Hexalob Screws Recalled for Risk of Fracture During Use
FDA (Devices) · 2026-07-01
- HighBiomet G7 Acetabular System Positioning Guide Rod Recalled for Fracture Risk
FDA (Devices) · 2014-06-25
- HighAcumed Recalls Tension Band Pins Due to Steel Specification Defect
FDA (Devices) · 2014-05-07
- SevereBiomet Recalls HipLOC Hip Fracture Fixation System Plates
FDA (Devices) · 2018-10-03