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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68500

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

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Event summary

Timeline bucket
May 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker 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

Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol.

Z-1978-2014
Recall number
Z-1978-2014
Initiated
May 01, 2014
Classification
Class II
Status
Terminated
Quantity
22 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tritanium Patella Inserter Instrument fracture during implantation. .

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tritanium Patella Inserter Instrument fracture during implantation. .

Code information

Catalog No. 6541-3-530. Lot Codes: CTD2778 and CTD2779.

Distribution pattern

US Nationwide Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.