Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86099

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

Open FDA event record

Event summary

Timeline bucket
July 22, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smith & Nephew Orthopaedics AG

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

POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is positioned on the rasp. The calcar reamer (75102207 or 75102208) is placed over the reamer guide and the femoral neck is machined until the reamer reach the physical stop-fully seated on the inner reamer guide.

Z-2827-2020
Recall number
Z-2827-2020
Initiated
July 22, 2020
Classification
Class II
Status
Ongoing
Quantity
528 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Multiple lots being recalled due to a product design issue

Code information

Serial Numbers: A56281, A57539, A58660, A600630, A61590, A62616 & A62689

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the state of TN and the countries of AU, BE, CA, CH, ES, FR, GB, JP, NL, NO, PL, SG, ZA.