Avenir recallZ-0644-2019 · Zimmer GmbH · initiated Oct 31, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-0644-2019
- Status
- Terminated
- Initiated by the company
- Oct 31, 2018
- Recalling firm
- Zimmer GmbH
- Quantity
- 13 units
- Product code
- LZO
- FDA submissions
- K123392
- Distribution
- International distribution in the countries of Germany and Switzerland.
Product description
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.
Code information (models, lots, serial numbers)
Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Avenir® 01.06010.001Zimmer GmbH · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall4 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K123392 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Avenir® Müller 01.06010.005Zimmer GmbH · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Avenir® Müller 01.06010.102Zimmer GmbH · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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