Depuy Recalls Custom Implants Due to FDA Concerns

DePuy Orthopaedics has recalled all unused custom implants as part of its efforts to remediate FDA GMP and quality system issues raised in a Warning Letter issued last January. The company has already stopped making custom implants, and the recall involves any unused product in the marketplace. In a letter to healthcare professionals, DePuy said FDA had identified concerns about its “interpretation of the custom device definition.”

The Warning Letter cited a 2011 inspection that found that the company was using a number of components for ankle, hip, shoulder, elbow, and wrist replacement systems that were not approved by the agency.

In response, Depuy said it distributed the devices without clearance or approval under the belief that they were custom devices. However, CDRH said that they do not deviate from generally available devices or from applicable performance standards, and they have common, standardized design characteristics, chemical and material compositions, or manufacturing processes.

Although the devices’ size and shape may vary with each patient’s anatomy, the Center‘s letter also explained that the standardized design characteristics do not vary among the devices manufactured. The fact that final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices, it concluded.