Encore Medical AltiVate Reverse Small Socket Insert Recall: Mislabeling Risks Surgery
Encore Medical recalls AltiVate Reverse Small Socket Insert (Part 509-03-044) due to mislabeling that may delay or stop surgery. Affected units sold with lot number 964W100:1000.
Lower-risk recall
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Contact the company
What happened, in plain English
Encore Medical is recalling a specific shoulder surgery implant part because it's mislabeled, which could delay or stop surgery. This affects patients who need shoulder replacements and may require revision surgery. Read more at govinfonow.com/recall/64392-encore-medical-altivate-reverse-small-socket-insert-recall-mislabeling-risks.
Source Summary by GovInfoNow · govinfonow.com/recall/64392-encore-medical-altivate-reverse-small-socket-insert-recall-mislabeling-risks · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0117-2021
Cite this page
“Encore Medical AltiVate Reverse Small Socket Insert Recall: Mislabeling Risks Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64392-encore-medical-altivate-reverse-small-socket-insert-recall-mislabeling-risks. Based on FDA recall #Z-0117-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0117-2021%22&limit=1).
Why it’s dangerous
The product is mislabeled, meaning it might not be the correct implant for surgery. This could lead to delays, stopping, or needing revision surgery if used incorrectly.
Who’s affected
Patients undergoing shoulder arthroplasty procedures are most affected. The recall targets specific units sold with lot number 964W1000.
How to tell if you have this one
Check for the part number 509-03-044 on the product. Affected units were sold with lot number 964W1000.
- Brand
Encore Medical- Category
Medical device
What to do — step by step
Check Product Label
Look for the part number 509-03-044 and lot number 964W1000 on the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury?
The recall states mislabeling may delay or stop surgery, but no specific injury risk is mentioned.
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Where this comes from
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-0117-2021 (August 31, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0117-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.