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Terminated

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

FDA Recall Z-2849-2020 · Posted None

Recalling FirmConformis, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2020-07-20
Date Terminated2021-06-21
Product Quantity1 kit

Reason for Recall

Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

Firm Action

Conformis notification to field sales representative on July 20,2020 to remove product from use.

Root Cause

Packaging process control

Distribution Pattern

NV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018-05-16

Official Source

View FDA Recall →

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

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