Zimmer Biomet Holding, Inc.
Product: iAssist Knee System
Date: 5/27/2016
8. Failure to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. For example:
a. Your firm initiated a correction in November 2007 and May 26, 2008, for the Orthosoft Knee Universal CAS Software 2.3.2, due to a complaint relating to Right/Left knee Selection issues, Extension/Flexion Gap Assessment issues, and the SKS incorrect offset parameter value. Your firm conducted a correction or removal of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
b. Your firm initiated a removal in June 2008, of Sesamoid Plasty CAS workstation/base and column assemblies 52 1.025 in the field, because the workstation could potentially collapse and fall on a user if an attempt was made to fold the workstation without first removing the camera and arm. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
c. Your firm initiated a removal in 2008, of Unicondylar Digitizer 108.098 instruments from the field, due to feedback received from surgeon that the newly modified software application was incompatible with the Unicondylar Digitizer instrument, causing large off-scale errors. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
d. Your firm initiated a correction in July and August 2008, for the Magnetic Offset Paddle 108.117, due to a complaint relating to Anterior Cortex Digitization, Implant Tolerance Interpretation Issues, and Software Issues. Your firm conducted a correction of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
e. Your firm initiated a removal in October 2010, of NDI P7 Position Sensors, because the camera components of the sensor could potentially malfunction, resulting in an interruption of the CAS system, and causing the display of positional data to stop during surgery. Your firm conducted a removal of these devices; however, no report was filed to FDA within 10 working days of initiating this removal.
f. Your firm initiated a correction in December 2011 for the Orthosoft Knee Universal CAS Software 2.3.2, due to a complaint that the software can malfunction, resulting in stalling during the preoperative calibration of the Universal Holding Platform, which in tum causes a delay in surgery or the need to complete the surgery using a conventional surgical technique. Your firm conducted a correction of these devices; however, no report was filed to FDA within 10 working days of initiating this correction.
Your firm’s response did not address this deficiency.
FDA District: CDRH
