Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ 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-0600-2018 · Posted None
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Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-07-24
Date Terminated2019-02-01
Product Quantity2 units
Reason for Recall
Implant kit mislabeled
Firm Action
On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001.
Root Cause
Employee error
Distribution Pattern
US Distribution to the states of :CA and TX.
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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