CLASS II Device recall · Reported 23 Jan 2019 · FDA Enforcement Report
iTotal Hip Replacement System, Total Hip Replacement System recalled
Conformis is recalling iTotal Hip Replacement System, Total Hip Replacement System, distributed in Tennessee. The recall was initiated on 16 Oct 2018 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-0731-2019
- FDA event ID
- 81723
- Recalling firm
- Conformis, Billerica, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2018
- FDA classified
- 11 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 16 Oct 2018 | Recall initiated by company | |
| 11 Jan 2019 | Classified by FDA | +87 days |
| 23 Jan 2019 | 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
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Product as listed by the FDA
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Where it was distributed
The products were distributed to the following US states: TN.
Questions about this recall
Is iTotal Hip Replacement System, Total Hip Replacement System recalled?
Yes. Conformis recalled iTotal Hip Replacement System, Total Hip Replacement System on 16 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0731-2019.
Why was it recalled?
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Which lots are affected?
Serial Number 0424647
Where was it sold?
The products were distributed to the following US states: TN.
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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