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.
Reported: December 2, 2020 Initiated: September 21, 2020 #Z-0475-2021
Product Description
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.
Reason for Recall
Incorrect hip components were provided in kits.
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 2
- Distribution
- US Distribution in CA.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Conformis, Inc.. Units affected: 2.
Why was this product recalled? ▼
Incorrect hip components were provided in kits.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0475-2021.
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