ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
FDA device recall Z-0142-2016 · posted 2015-10-21 · Terminated
Recall details
- Recalling firm
- ConforMIS, Inc.
- Reason for recall
- May contain small amounts of ethylene glycol residue
- Action taken
- 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
- Status
- Terminated
- Product code
- NPJ
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Date initiated
- 2015-08-31
- Date posted
- 2015-10-21
- Date terminated
- 2016-03-02
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K133256) | Conformis, Inc. | 2014-01-09 |
| IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513) | Conformis, Inc. | 2009-12-16 |