Exact FDA event identifier

Event 77827

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

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Event summary

Timeline bucket: July 24, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Smith & Nephew, Inc.

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

smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument

Z-3100-2017

Recall number: Z-3100-2017
Initiated: July 24, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 402 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Reason for recall

The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.

Code information

Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.