ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
FDA Recall Z-0140-2016 · Posted 2015-10-21
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Recalling FirmConforMIS, Inc.
Recall StatusTerminated
Product CodeOOG
Date Initiated2015-08-31
Date Terminated2016-03-02
Product Quantity6 units
Reason for Recall
May contain small amounts of ethylene glycol residue
Firm Action
ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below:
Phase 1-Surgeons with product for which the surgery has not yet been completed
Phase 2-Surgeons for whom product was confirmed to have been
consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery.
Contact your local ConforMIS representative or Amita Shah, at 17813459164.
Root Cause
Process design
Distribution Pattern
Distributed Nationwide and in Germany, Switzerland, and UK.
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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