ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
FDA Recall Z-0658-2017 · Posted None
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Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-10-18
Date Terminated2016-12-07
Product Quantity2 units
Reason for Recall
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Firm Action
ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
Root Cause
Labeling Change Control
Distribution Pattern
Distributed to the states of CO and NV.
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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