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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75969

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

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Event summary

Timeline bucket
October 31, 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 PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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-0991-2017
Recall number
Z-0991-2017
Initiated
October 31, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConforMIS, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).

Code information

Serial Number: 0384180

Distribution pattern

Distribution to TX only