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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87517

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

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Event summary

Timeline bucket
March 05, 2021
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

Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting Guide Size 1 Left I-K3834CG1R Specialty Triathlon TS Trial Cutting Guide Size 1 Right I-K3834CG2L Specialty Triathlon TS Trial Cutting Guide Size 2 Left I-K3834CG2R Specialty Triathlon TS Trial Cutting Guide Size 2 Right I-K3834CG3L Specialty Triathlon TS Trial Cutting Guide Size 3 Left I-K3834CG3R Specialty Triathlon TS Trial Cutting Guide Size 3 Right I-K3834CG4L Specialty Triathlon TS Trial Cutting Guide Size 4 Left I-K3834CG4R Specialty Triathlon TS Trial Cutting Guide Size 4 Right I-K3834CG5L Specialty Triathlon TS Trial Cutting Guide Size 5 Left I-K3834CG5R Specialty Triathlon TS Trial Cutting Guide Size 5 Right I-K3834CG6L Specialty Triathlon TS Trial Cutting Guide Size 6 Left I-K3834CG6R Specialty Triathlon TS Trial Cutting Guide Size 6 Right I-K3834CG7L Specialty Triathlon TS Trial Cutting Guide Size 7 Left I-K3834CG7R Specialty Triathlon TS Trial Cutting Guide Size 7 Right I-K3834CG8L Specialty Triathlon TS Trial Cutting Guide Size 8 Left I-K3834CG8R Specialty Triathlon TS Trial Cutting Guide Size 8 Right

Z-1379-2021
Recall number
Z-1379-2021
Initiated
March 05, 2021
Classification
Class II
Status
Terminated
Recalling firm
Howmedica Osteonics Corp.
Quantity
113 components

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

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.

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Inspect official wording and provenance

Reason for recall

The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

Code information

All Lot numbers for each GTIN: GTIN: 07613327327595 GTIN: 07613327327533 GTIN: 07613327327748 GTIN: 07613327329209 GTIN: 07613327329193 GTIN: 07613327329100 GTIN: 07613327329087 GTIN: 07613327329063 GTIN: 07613327328899 GTIN: 07613327328868 GTIN: 07613327328707 GTIN: 07613327328691 GTIN: 07613327328592 GTIN: 07613327328530 GTIN: 07613327328639 GTIN: 07613327328424 GTIN: 07613327328288

Distribution pattern

Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada