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Completed

iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101

FDA Recall Z-0899-2022 · Posted None

Recalling FirmConformis, Inc.
Recall StatusCompleted
Product CodeJWH
Date Initiated2022-02-22
Product Quantity1 unit

Reason for Recall

Incorrect tibial base plate implant packaged in kit

Firm Action

Conformis issued Notifications to Conformis sales representative via phone conversation. The sales representative spoke with the respective surgeons on 2/22/22 to retrieve the product. No phone script was saved.

Root Cause

Nonconforming Material/Component

Distribution Pattern

MS

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc. · 2021-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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