CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report
iTotal CR Knee Replacement System- Itotal CR - Ipoly recalled
ConforMIS is recalling ConFormis iTotal CR Knee Replacement System- Itotal CR - Ipoly - Implant Kit Uncaptured, 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-0144-2016
- 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 iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Where it was distributed
Distributed Nationwide and in Germany, Switzerland, and UK.
Questions about this recall
Is iTotal CR Knee Replacement System- Itotal CR - Ipoly - Implant Kit Uncaptured - Left recalled?
Yes. ConforMIS recalled iTotal CR Knee Replacement System- Itotal CR - Ipoly - Implant Kit Uncaptured - Left on 31 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-0144-2016.
Why was it recalled?
May contain small amounts of ethylene glycol residue
Which lots are affected?
Serial Numbers (US): 0354697, 0353789, 0354533
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
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