The FDA sent Johnson & Johnson a letter of warning because the company improperly marketed two products under the DePuy Orthopaedics unit, according to a redOrbit.com report.
The FDA ordered J&J to stop marketing the TruMatch Personalized Solutions System and the Corail Hip System for certain uses until they are awarded proper regulatory approvals. Currently, the Corail Hip System is approved for total hip replacements in patients with six specific types of hip damage, though DePuy's website states two additional conditions the system could treat.
Read the redOrbit.com report on the FDA's letter of warning.
Read other coverage on FDA approvals:
- 26 Orthopedic and Spine Devices Receive FDA Clearance in July
- Kent Medical Devices Receives FDA Clearance for Device Detecting Soft Tissue Sites
- FDA Panel Votes to Recommend Approval for Medtronic's Amplify Spine Device
The FDA ordered J&J to stop marketing the TruMatch Personalized Solutions System and the Corail Hip System for certain uses until they are awarded proper regulatory approvals. Currently, the Corail Hip System is approved for total hip replacements in patients with six specific types of hip damage, though DePuy's website states two additional conditions the system could treat.
Read the redOrbit.com report on the FDA's letter of warning.
Read other coverage on FDA approvals:
- 26 Orthopedic and Spine Devices Receive FDA Clearance in July
- Kent Medical Devices Receives FDA Clearance for Device Detecting Soft Tissue Sites
- FDA Panel Votes to Recommend Approval for Medtronic's Amplify Spine Device