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
FDA Recall Z-0991-2017 · Posted 2017-01-10
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Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-10-31
Date Terminated2017-01-11
Product Quantity1 unit
Reason for Recall
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Firm Action
ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit.
For questions regarding this recall call 781-345-9001.
Root Cause
Software Design Change
Distribution Pattern
Distribution to TX only
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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