Most recalled foot, ankle devices are 501(k) approved, study finds
- An analysis of foot and ankle device recalls published in the open access medical journal Cureus found that most of the recalled implants were approved through the 501(k) premarket notification process rather than the more stringent pre-market approval (PMA) process.
- The study evaluated all foot and ankle device recalls in the FDA recall database from 2007 through 2017. Of 161 devices recalled during the 10-year period, 158 (98.1%) were approved through the 510(k) process and only one product was authorized through the PMA process. The submission procedure was not indicated for two devices.
- The recalled products were manufactured by 33 different companies. The largest number of recalled products were screws made by Synthes, with nearly 19.5 million screws recalled due to labeling issues.
Orthopedic devices represent 12% of all medical device recalls, according to study authors Carl Pellerin and Vinod Panchbhavi of University of Texas Medical in Galveston and Cory Janney of the Naval Medical Center in San Diego.
The majority of orthopedic devices are used for procedures such as joint replacement (projected U.S. market of $10.3 billion in 2018) and fracture management (projected U.S. market of $4.3 billion in 2015), according to the Cureus article.
The researchers said they found no previous evaluation in the medical literature of recalls in the foot and ankle subspecialty, which has seen rapid growth in implant innovation in recent years.
The U.S. market for foot and ankle devices is projected to grow at an annual rate of 8% to 10%, to an estimated $2.8 billion in 2019, according to Wright Medical. Along with Johnson & Johnson’s DePuy Synthes unit, other device makers in the foot and ankle business include Stryker and Zimmer Biomet.
The most common reason foot and ankle products were recalled was for breaking during or after the operation, with one company recalling 78,594 suture anchors due to fractures of the hardware that required revision surgery, according to the study.
Device breakage accounted for 39 of the 161 device recalls in the analysis. The second most common reason for recall was sterility concerns, which accounted for 37 recalls, followed by labeling design (30), device design (27), manufacturing defect (22), software design (3), packaging issue (2) and employee error (1).
The less-demanding 510(k) process, which allows a company to fast-track approval of a device with a claim of substantial equivalency to another device, “may cause the devices to carry a greater risk to patients” due to a lack of clinical data, the researchers said.
”Claiming that one device is equivalent to another device may be illogical even when the predicate comes from the same company,” they said.