iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- Company
- Conformis, Inc.
- Recall Initiated
- January 4, 2019
- Terminated
- June 29, 2020
- Recall Number
- Z-1079-2019
- Quantity
- 2
- Firm Location
- Billerica, MA
Reason for Recall
The labeling of the boxes and sterile pouches did not match the contents.
Distribution
The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Lot / Code Info
Serial Numbers 0434436 and 0434836
Root Cause
Employee error
Action Taken
Emails were sent to the customers on 1/4/19 requesting return of the affected products.
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