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.
FDA Recall Z-0644-2019 · Posted None
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Recalling FirmZimmer GmbH
Recall StatusTerminated
Product CodeLZO
Date Initiated2018-10-31
Date Terminated2020-04-01
Product Quantity13 units
Reason for Recall
Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
Firm Action
Zimmer Biomet issued Notices to the OUS consignees on October 31, 2018. Letter identifies action to be taken: Review this notice and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement
Root Cause
Process control
Distribution Pattern
International distribution in the countries of Germany and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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