Drug recall
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is…
FDA recall event 81762 · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Event ID | 81762 |
|---|---|
| Recall numbers | Z-0728-2019, Z-0729-2019 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 4, 2018 |
| Report date | Jan 23, 2019 |
| Termination date | Jun 5, 2020 |
| City | Norderstedt |
| Country | Germany |
| FEI number | 3003386935 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: