Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81608

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

Open FDA event record

Event summary

Timeline bucket
October 31, 2018
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

Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.

Z-0644-2019
Recall number
Z-0644-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer GmbH
Quantity
13 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .

Code information

Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599

Distribution pattern

International distribution in the countries of Germany and Switzerland.