iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
FDA Recall Z-1079-2019 · Posted None
Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2019-01-04
Date Terminated2020-06-29
Product Quantity2
Reason for Recall
The labeling of the boxes and sterile pouches did not match the contents.
Firm Action
Emails were sent to the customers on 1/4/19 requesting return of the affected products.
Root Cause
Employee error
Distribution Pattern
The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.