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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89619

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Orthosoft, Inc. dba Zimmer CAS

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

NavitrackER Kit A: Knee, Model Number 20-8000-000-07,

Z-0721-2022
Recall number
Z-0721-2022
Initiated
January 07, 2022
Classification
Class II
Status
Ongoing
Quantity
14 units US; 132 units OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

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

The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention.

Code information

Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of AR, NY, OH, TN, TX and the countries of Canada and the Netherlands.