Exact FDA event identifier

Event 75553

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

Open FDA event record

Event summary

Timeline bucket: October 18, 2016
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

ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.

Z-0658-2017

Recall number: Z-0658-2017
Initiated: October 18, 2016
Classification: Class II
Status: Terminated
Recalling firm: ConforMIS, Inc.
Quantity: 2 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.

Code information

Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28

Distribution pattern

Distributed to the states of CO and NV.