Z-0991-2017 Class II Terminated
FDA device recall Z-0991-2017 was initiated by ConforMIS, Inc. on October 31, 2016 and is designated Class II. Reason for recall: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm). The recall status is terminated (terminated January 11, 2017). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- October 31, 2016
- Termination Date
- January 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
Reason for Recall
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Distribution Pattern
Distribution to TX only
Code Information
Serial Number: 0384180