Although Smith & Nephew has not yet seen the Dec. 21 letter of warning from the FDA, the company has responded that the supply of its R3 Ceramic Acetabular Systems for hip replacement will not be affected by the U.S. regulator's concerns over manufacturing procedures in the Tuttlingen, Germany, plant, according to a Reuters news report.
Concerns were initially raised over quality control at the company’s German plant in July, when German inspectors cited the company for multiple quality control problems. The letter states that the company did not document several production steps and asked that the company respond to the letter within 15 business days.
The company said it took remedial action to solve the issues raised by the FDA in July and can continue to meet demand for device production at other plants, according to the report. There have not been any reports of patient incidence connected to this issue; however, company stock fell 2 percent after the FDA’s warning was reported.
Read the Reuters report on Smith & Nephew.
Read other coverage on the FDA:
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
- Medtronic Receives First FDA Clearance in Pediatric AIS Category for CD Horizon Spinal System
- Titan Spine Receives FDA 510(k) Clearance on PLIF Device
Concerns were initially raised over quality control at the company’s German plant in July, when German inspectors cited the company for multiple quality control problems. The letter states that the company did not document several production steps and asked that the company respond to the letter within 15 business days.
The company said it took remedial action to solve the issues raised by the FDA in July and can continue to meet demand for device production at other plants, according to the report. There have not been any reports of patient incidence connected to this issue; however, company stock fell 2 percent after the FDA’s warning was reported.
Read the Reuters report on Smith & Nephew.
Read other coverage on the FDA:
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
- Medtronic Receives First FDA Clearance in Pediatric AIS Category for CD Horizon Spinal System
- Titan Spine Receives FDA 510(k) Clearance on PLIF Device