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.
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: 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 holes
- Manufacturer
- Acumed LLC
- Hazard
- Affected units
- 513
Distribution
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