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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79597

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

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Event summary

Timeline bucket
December 20, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences 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.

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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

The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm

Z-1463-2018
Recall number
Z-1463-2018
Initiated
December 20, 2017
Classification
Class II
Status
Terminated
Quantity
1619 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.

Code information

TRL092002506 Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177 TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178 TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179 TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710 TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711 TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712 TRL092002512 Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713 TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714 TRL092002514 Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715 TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716 TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717

Distribution pattern

Worldwide Distribution - USA (nationwide) Distribution.