Recall Z-0475-2021— Conformis, Inc.
Class II · Terminated
Class II FDA medical device recall by Conformis, Inc., initiated 2020-09-21, terminated 2023-06-12. It names one FDA 510(k) clearance: K192198. Product: 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: Incorrect hip components were provided in kits..
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-21
- Terminated
- 2023-06-12
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.