Exact FDA event identifier

Event 84315

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: October 25, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Conformis, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

Z-0672-2020

Recall number: Z-0672-2020
Initiated: October 25, 2019
Classification: Class II
Status: Terminated
Recalling firm: Conformis, Inc.
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.

Code information

Serial Number: 0450585

Distribution pattern

US Nationwide distribution in the state of GA.