iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Reported: April 10, 2019 Initiated: January 4, 2019 #Z-1079-2019
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.
Details
- Recalling Firm
- Conformis, Inc.
- Units Affected
- 2
- Distribution
- The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102. Recalled by Conformis, Inc.. Units affected: 2.
Why was this product recalled? ▼
The labeling of the boxes and sterile pouches did not match the contents.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2019. Severity: Moderate. Recall number: Z-1079-2019.
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