CLASS II Device recall · Reported 2 Dec 2020 · FDA Enforcement Report
iTotal Hip Replacement System recalled by Conformis
Conformis is recalling iTotal Hip Replacement System, distributed in California. The recall was initiated on 21 Sep 2020 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-0475-2021
- FDA event ID
- 86615
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2020
- FDA classified
- 20 Nov 2020
- Reported
- 2 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 21 Sep 2020 | Recall initiated by company | |
| 20 Nov 2020 | Classified by FDA | +60 days |
| 2 Dec 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect hip components were provided in kits.
Product as listed by the FDA
iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Where it was distributed
US Distribution in CA.
Questions about this recall
Why was it recalled?
Incorrect hip components were provided in kits.
Which lots are affected?
Serial numbers 0469255, 0469255
Where was it sold?
US Distribution in CA.
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.
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