Waldemar Link BiMobile UHMWPE Liner: Incorrect Labels Risk Patient Misidentification
Waldemar Link recalls BiMobile UHMWPE Liner (ID-28mm/OD-54mm, Ref 184-260/04) due to potential incorrect part numbers in labeling that could lead to patient record errors. Affected patients should contact the manufacturer for guidance.
Lower-risk recall
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Contact the company
What happened, in plain English
Waldemar Link is recalling BiMobile UHMWPE Liners with specific dimensions and reference numbers because their internal labels might have wrong part numbers. This could cause patient records to be misidentified, which is risky for medical treatment. Read more at govinfonow.com/recall/69389-waldemar-link-bimobile-uhmwpe-liner-incorrect-labels-risk-patient-misidentification.
Source Summary by GovInfoNow · govinfonow.com/recall/69389-waldemar-link-bimobile-uhmwpe-liner-incorrect-labels-risk-patient-misidentification · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0729-2019
Cite this page
“Waldemar Link BiMobile UHMWPE Liner: Incorrect Labels Risk Patient Misidentification.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69389-waldemar-link-bimobile-uhmwpe-liner-incorrect-labels-risk-patient-misidentification. Based on FDA recall #Z-0729-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0729-2019%22&limit=1).
Why it’s dangerous
The internal labels on these implants might have incorrect part numbers. If these wrong labels are added to patient records, it could lead to misidentification of patients during medical procedures.
Who’s affected
Patients using the BiMobile UHMWPE Liner implants with the specified dimensions and reference number are affected. Those with mobility-limiting conditions, fractures, or defects treated with this device are most at risk.
How to tell if you have this one
Check for the BiMobile UHMWPE Liner with ID-28mm/OD-54mm and reference number 184-260/04. The device is used for mobility-limiting conditions, fractures, or defects that require surgical treatment.
- Brand
Waldemar Link- 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
US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0728-2019 | BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.; Lot# 1707121 | 30 |
| Z-0729-2019 | BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.; Lot# 1707116 | 31 |
What to do — step by step
Contact Manufacturer
Reach out to Waldemar Link for guidance on whether the labels need correction or if patient records should be updated.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Florida, Georgia, Louisiana, Michigan, Minnesota, Texas, Washington.
Recall timeline
FDA terminated this recall 18 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.
Questions people ask
Is there a risk of serious injury?
The recall is due to potential misidentification in patient records, not a direct physical hazard to the user.
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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-0729-2019 (December 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0729-2019 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.