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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70100

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

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Event summary

Timeline bucket
December 15, 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

Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

Z-1043-2015
Recall number
Z-1043-2015
Initiated
December 15, 2014
Classification
Class II
Status
Terminated
Quantity
seven units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

Code information

510K 983382 Lot code 49073501

Distribution pattern

Nationwide Distribution including NY, OH, PA, and TX.