CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report
Unicondylar Knee Replacement System iUNI G2, Left Medial recalled
ConforMIS is recalling Unicondylar Knee Replacement System iUNI G2, Left Medial, distributed nationwide in the US. The recall was initiated on 31 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0139-2016
- FDA event ID
- 72108
- Recalling firm
- ConforMIS, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Aug 2015
- FDA classified
- 21 Oct 2015
- Reported
- 28 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 31 Aug 2015 | Recall initiated by company | |
| 21 Oct 2015 | Classified by FDA | +51 days |
| 28 Oct 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May contain small amounts of ethylene glycol residue
Product as listed by the FDA
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
Where it was distributed
Distributed Nationwide and in Germany, Switzerland, and UK.
Questions about this recall
Why was it recalled?
May contain small amounts of ethylene glycol residue
Which lots are affected?
Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227
Where was it sold?
Distributed Nationwide and in Germany, Switzerland, and UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 72108This product is part of a recall event; the main page for the event is iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral recalled.
More recalls from ConforMIS
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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |