Z-0475-2021 Class II Terminated
FDA device recall Z-0475-2021 was initiated by Conformis, Inc. on September 21, 2020 and is designated Class II. Reason for recall: Incorrect hip components were provided in kits. The recall status is terminated (terminated June 12, 2023). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2020
- Initiation Date
- September 21, 2020
- Termination Date
- June 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
US Distribution in CA.
Code Information
Serial numbers 0469255, 0469255