Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 23, 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.
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Waldemar Link GmbH & Co. Kg (Mfg Site) recalled BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile … - a moderate-severity action.
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile … was recalled by Waldemar Link GmbH & Co. Kg (Mfg Site) in January 23, 2019. Reason: The internal labeling included with these implants may include incorrect part numbers and could result in the…. Check the official notice for the remedy. Verify recall #Z-0728-2019 with the FDA Devices before acting.
The recall
Waldemar Link GmbH & Co. Kg (Mfg Site) issued this moderate-severity FDA Devices recall-The internal labeling included with these implants may include incorrect part numbers and could result in the….
- Moderate
- severity level
- 30 units
- affected scope
- Class II
- classification
- January 23, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0728-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0728-2019) was formally reported on January 23, 2019, with the manufacturer initiating the action on December 4, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Waldemar Link GmbH & Co. Kg (Mfg Site) is listed as the recalling firm, operating out of Norderstedt. Federal records list the affected scope as 30.
The documented reason for this recall is: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. Distribution data in the federal record shows the product reached: US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.. 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
30
Related Recalls
6
0 from same agency
Product description
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.
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0728-2019 |
| Date reported | January 23, 2019 |
| Date initiated | December 4, 2018 |
| Recalling firm | Waldemar Link GmbH & Co. Kg (Mfg Site) |
| Firm location | Norderstedt |
| Affected scope | 30 |
| Distribution | US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA. |
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-0728-2019) 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? ▼
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.. Recalled by Waldemar Link GmbH & Co. Kg (Mfg Site). Units affected: 30.
Why was this product recalled? ▼
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0728-2019.
Where was the recalled product distributed? ▼
Distribution: US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0728-2019) 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 January 23, 2019. 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.