Device recall
Z-0729-2019: BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK…
FDA device recall · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Recall number (Z-number) | Z-0729-2019 |
|---|---|
| Recall event | 81762 |
| Product | 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… |
| Product code | MEH |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2020 |
| 510(k) numbers | K171273 |
| FEI number | 3003386935 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database