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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74206

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

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Event summary

Timeline bucket
May 17, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Gmbh

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

Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.

Z-2003-2016
Recall number
Z-2003-2016
Initiated
May 17, 2016
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Gmbh
Quantity
177

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

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

In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.

Code information

Item Number: 01.04227.005 Lot Numbers: 2792457 2794578 2812029 2817212 2844463 2794576 2794579 2815118 2817213 2847568 2794577 2794580 2815119 2832862

Distribution pattern

Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.