The Recall Desk
HighFDA (Devices)·Z-0852-2014·Announced 2014-02-05

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.

What this means for you

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 manufact
Manufacturer
ACUTE Innovations, LLC
Category
Medical Device — Orthopedic Implant
Hazard
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

Distributed in 6 states:

Related recalls

Same hazard · malfunction

See all →