Z-0141-2016Class II
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US)...
ConforMIS, Inc. / initiated 2015-08-31 / Terminated / root cause: manufacturing process
ConforMIS, Inc. began a recall of ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS) on . FDA classified it as Class II and gives the reason as "May contain small amounts of ethylene glycol residue". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0141-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ConforMIS, Inc.
- Product
- ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- May contain small amounts of ethylene glycol residue
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- 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.
- Quantity in commerce
- 68 units
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
- Product codes and lots
- Serial Numbers (US): 0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS): 0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0138-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0139-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0140-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0141-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0142-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0143-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0144-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0145-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0146-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0147-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0148-2016 | Class II | Terminated | Voluntary: Firm initiated |
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