Device product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Z-1079-2019
Product summary
- Firm
- Conformis, Inc.
- Event
- Event 82101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1079-2019
Official wording
Reason: The labeling of the boxes and sterile pouches did not match the contents.
Code information: Serial Numbers 0434436 and 0434836
Distribution pattern: The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Derived failure modes
-
Unknown
The labeling of the boxes and sterile pouches did not match the contents.