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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79661

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

Open FDA event record

Event summary

Timeline bucket
January 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Howmedica Osteonics Corp.

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

Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

Z-1512-2018
Recall number
Z-1512-2018
Initiated
January 12, 2018
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
6 units of catalog 5521-B-400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

Code information

Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Distribution pattern

Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.