Zimmer recalls Avenir Muller Stem Standard size 1 due to mislabeling in packaging. The stem inside packaging is actually size 2, which could lead to improper fit during hip surgery.
“Zimmer Avenir Muller Stem Recall: Mislabeled Size 1 Product.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69539-zimmer-avenir-muller-stem-recall-mislabeled-size-1-product. Based on FDA recall #Z-0644-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0644-2019%22&limit=1).
The FDA announced on Oct. 31, 2018, that Zimmer GmbH voluntarily recalled Avenir Muller Stem Standard implants due to mislabeling hazards. The agency issued recall number Z-0644-2019 for the Class II device distributed in Germany and Switzerland.
The recall addresses a hazard where the labeled Avenir Muller Stem size 1 contains a size 2 stem inside the packaging. This mislabeling affects 13 units of the product.
Context
GovInfoNow's records show Zimmer GmbH has had six other recalls on record since Feb. 28, 2018. Other recent recalls of similar products include Zimmer Biolox Option Taper Sleeve (Aug. 8, 2024), Zimmer Natural Nail (May 7, 2021), and Zimmer Sidus Shoulder Implant (Aug. 21, 2019). Similar recent packaging or labeling issues include Straumann GM Helix Implant (Aug. 12, 2026), EMPOWR 3D Knee Ins (Feb. 16, 2026), and Micro Therapeutics Pipeline Flex Embolization Device (June 8, 2026).
How to tell if you have this one
Check for the product name 'Avenir Muller Stem Standard', item number 01.06010.001, and lot number 2955599. The stems are intended for total or hemi-hip arthroplasty procedures.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0644-2019 (October 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0644-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.