Z-0063-2020 Class II Terminated
FDA device recall Z-0063-2020 was initiated by Conformis, Inc. on August 22, 2019 and is designated Class II. Reason for recall: Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. The recall status is terminated (terminated July 8, 2020). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 22, 2019
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Reason for Recall
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Distribution Pattern
Distributed to consignees in MD and NV.
Code Information
0448088