Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2018
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 provi
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer GmbH recalled Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - P… - a moderate-severity action.
Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - P… was recalled by Zimmer GmbH in December 26, 2018. Reason: Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .. Check the official notice for the remedy. Verify recall #Z-0644-2019 with the FDA Devices before acting.
The recall
Zimmer GmbH issued this moderate-severity FDA Devices recall-Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 ..
- Moderate
- severity level
- 13 units
- affected scope
- Class II
- classification
- December 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0644-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0644-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on October 31, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer GmbH is listed as the recalling firm, operating out of Winterthur. Federal records list the affected scope as 13 units.
The documented reason for this recall is: Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 . Distribution data in the federal record shows the product reached: International distribution in the countries of Germany and Switzerland.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13 units
Related Recalls
6
0 from same agency
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.
Reason for recall
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0644-2019 |
| Date reported | December 26, 2018 |
| Date initiated | October 31, 2018 |
| Recalling firm | Zimmer GmbH |
| Firm location | Winterthur |
| Affected scope | 13 units |
| Distribution | International distribution in the countries of Germany and Switzerland. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0644-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer GmbH. Units affected: 13 units.
Why was this product recalled? ▼
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2018. Severity: Moderate. Recall number: Z-0644-2019.
Where was the recalled product distributed? ▼
Distribution: International distribution in the countries of Germany and Switzerland..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0644-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.