Conformis iTotal Hip Replacement System Model HBS-033-001: Switched Stems Risk
Conformis recalls hip replacement stems Model HBS-033-0015-020101 Size 15 due to switched packaging. Patients may receive incorrect stem size.
Lower-risk recall
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Contact the company
What happened, in plain English
Conformis is recalling a specific hip replacement stem model because two different sizes were accidentally switched in the packaging. This could lead to improper implantation if the wrong size is used. Read more at govinfonow.com/recall/67112-conformis-itotal-hip-replacement-system-model-hbs-033-001-switched.
Source Summary by GovInfoNow · govinfonow.com/recall/67112-conformis-itotal-hip-replacement-system-model-hbs-033-001-switched · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0063-2020
Cite this page
“Conformis iTotal Hip Replacement System Model HBS-033-001: Switched Stems Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67112-conformis-itotal-hip-replacement-system-model-hbs-033-001-switched. Based on FDA recall #Z-0063-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0063-2020%22&limit=1).
Why it’s dangerous
The stems for sizes 13 and 15 were mistakenly packed together. If a patient receives the wrong size stem during surgery, it could cause improper fit and potential complications.
Who’s affected
Patients who received the recalled hip replacement stem model HBS-033-0015-020101 Size 15 are affected. Those with the correct stem size are not at risk.
How to tell if you have this one
Check your hip replacement stem packaging for the model number HBS-033-0015-020101 and size 15. The product code 0448088 is also associated with this recall.
- Brand
Conformis- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distributed to consignees in MD and NV.
| Recall number | Product, codes & lots |
|---|---|
| Z-0063-2020 | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right; 0448088 |
| Z-0064-2020 | iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right; 0447621 |
What to do — step by step
Check Your Stem Packaging
Look for the model number HBS-033-0015-020101 and size 15 on the packaging.
Where it went and when
Where it was distributed
Distributed in Maryland and Nevada.
FDA distribution: “Distributed to consignees in MD and NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Maryland, Nevada.
Recall timeline
FDA terminated this recall 11 months 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.
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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-0063-2020 (August 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0063-2020 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.