CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report
iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral recalled
ConforMIS is recalling iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral, 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-0138-2016
- 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 iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (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): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849
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 72108More recalls from ConforMIS
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | restor3d Cordera Hip System recalled by Conformis | Conformis | Labeling Errors | Nationwide |
| Device | CLASS II | Identity Imprint PS Tibial Tray Size recalled by Conformis | Conformis | Packaging Defects | Nationwide |
| Device | CLASS II | Hip-screw-, Sterile Eo recalled by Conformis | Conformis | Other | Nationwide |
| Device | CLASS II | iTotal Identity Impactor Handle recalled by Conformis | Conformis | Device Malfunction | Nationwide |
| Device | CLASS II | iTotal Identity Posterior Stabilised (PS) Knee Replacement System recalled | Conformis | Packaging Defects | MS |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |