Recall Trends of FDA-Cleared Shoulder and Elbow Devices.

BACKGROUND The requirements for medical device approvals are based on the classification and the associated risks. Based on the type of approval, there can be a higher risk of recall for orthopedic medical devices. The purpose of this study is to analyze the risk of recall for shoulder/elbow devices.

MATERIALS AND METHODS A retrospective review was conducted of publicly available U.S. Food and Drug Administration (FDA) databases to identify cleared for market and recalled shoulder and elbow devices. Non-orthopedic and unrelated devices were excluded. Data on approval date, recall date, and reason for recall were extracted. Recall reasons were categorized using a previously published classification into device design, manufacturing, processing, packaging, sterility, software or marketing. Descriptive statistics were used to calculate recall rates, categorize recall types, and assess time from approval to recall.

RESULTS A total of 669 shoulder and elbow medical devices were cleared through a 510(k) from 1979 to 2025. Out of this list, 128 devices had at least one recall within this time period. Majority of these recalls were classified as a Class II risk with device design listed as the most common reason for recall stating issues such as increased risk of fracture, wear, loosening and misalignment.

CONCLUSION FDA clearance for shoulder and elbow devices has steadily increased since 1979, with nearly all devices classified as Class II and cleared through the 510(k) clearance. No devices were found to be approved through PMA or De Novo pathways. Overall, 19.1% of devices had at least one recall, most commonly due to design flaws and classified as Class II recalls. These findings align with trends seen in other orthopedic subspecialties and highlight limitations in premarket testing under the 510(k) process. As most Class II devices are cleared without additional pivotal trials, surgeons should remain cautious when adopting new technologies.