ACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk
ACUTE Innovations is recalling 176 units of the RibLoc U plus system because the implants may malfunction during surgical installation.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical implant malfunction) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria.
Plain-English summary
ACUTE Innovations, LLC is recalling 176 units of the ACUTE Innovations Modular RibLoc System (RibLoc U plus). This medical device consists of titanium plates and screws used to stabilize rib fractures, fusions, and osteotomies. The recall is being conducted because the system has the potential to malfunction during installation in a surgery.
The affected units were distributed in the United States to the states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin. Specific lot numbers for the 50 mm, 75 mm, 115 mm, 155 mm, and 215 mm rib plates are listed in the official recall documentation.
Healthcare providers and patients should contact ACUTE Innovations, LLC for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are…
- Manufacturer
- ACUTE Innovations, LLC
- Affected units
- 176
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- LOT numbers: RBL1301 for 50 mm Rib Plate: L1209002
- L1302002
- L1308001
- RBL1302 for 75 mm Rib Plate: L1209003
- L1302003
- RBL1303 for 115 mm Rib Plate: L1209004
- L1302004
- RBL1304 for 155 mm Rib Plate: L1209005
- RBL1305 for 215 mm Rib Plate: L1209006
Distribution
Related recalls
Same hazard · malfunction
See all →- ModerateCriticare nGenuity Patient Monitor Recalled for Capnography Setup Error
FDA (Devices) · 2026-09-30
- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
Similar recalls
- HighAcumed RibLoc U Plus 90 Surgical Guide Recalled for Potential Breakage
FDA (Devices) · 2024-01-03
- HighAcuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect
FDA (Devices) · 2020-06-17
- ModerateReverse Shoulder Joint Implant System Recalled for Mislabeling
FDA (Devices) · 2024-01-10
- ModerateI.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking
FDA (Devices) · 2019-06-12
- HighUlrich Medical Recalls uNion Cervical Plate System for Screw Mechanism Defect
FDA (Devices) · 2017-05-03
- HighZimmer Recalls Trilogy Acetabular Shells with Porosity Defects
FDA (Devices) · 2013-02-13