Medical Device Recalls in Orthopedics: Recent Trends and Areas for Improvement.

Abstract

Medical device recalls have the potential to affect patient outcomes in orthopedic surgery. We assessed high-risk orthopedic medical device recalls in the recent past. The publicly available Food and Drug Administration medical device recall database was mined for information on class 1 and class 2 recalls of orthopedic implants or medical devices related to orthopedic surgery from January 1, 2015 to December 31, 2019. Recall details, including reason for recall, class of recall, and the recalling company, were recorded. The data were quantified and analyzed in Excel. The results of this study showed that orthopedic device recalls constitute a significant percentage of total medical device recalls, ranging from 11.8% to 21.5%. In the last 5 years, 2018 was the busiest year for all medical and orthopedic device recalls. Packaging errors were the most common reasons for orthopedic device recalls, followed by design flaws and manufacturing issues. Marketing and software issues were uncommon reasons for orthopedic device recalls. Zimmer Biomet, Johnson & Johnson (parent company of DePuy Synthes), and Stryker had the highest number of orthopedic device recalls over the last 5 years and also constitute the top 3 orthopedic companies with the largest market share of orthopedic implants. Orthopedic device recalls remain a significant concern and constitute, on average, 16.6% of all class II medical device recalls from 2015 to 2019. Manufacturing companies can reduce the number of orthopedic device recalls by improving their device design, manufacturing, and packaging stages of the production cycle. III.