iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Reported: January 23, 2019 Initiated: October 16, 2018 #Z-0731-2019
Product Description
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
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.
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 1
- Distribution
- The products were distributed to the following US states: TN.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101. Recalled by Conformis, Inc.. Units affected: 1.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0731-2019.
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