Z-1079-2019 Class II Terminated
FDA device recall Z-1079-2019 was initiated by Conformis, Inc. on January 4, 2019 and is designated Class II. Reason for recall: The labeling of the boxes and sterile pouches did not match the contents. The recall status is terminated (terminated June 29, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2019
- Initiation Date
- January 4, 2019
- Termination Date
- June 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Reason for Recall
The labeling of the boxes and sterile pouches did not match the contents.
Distribution Pattern
The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Code Information
Serial Numbers 0434436 and 0434836