BiMobile UHMWPE Liner: ID-28mm/OD-54mm — Class II medical device recall Z-0729-2019
Terminated recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2019-01-23, distributed in AZ, FL, GA, LA, MI, MN, TX, WA. The internal labeling included with these implants may include incorrect part numbers and could result in thes
| Recall number | Z-0729-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany |
| Recall initiated | 2018-12-04 |
| Classified | 2019-01-11 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-06-05 |
| Distributed | AZ, FL, GA, LA, MI, MN, TX, WA |
| Quantity | 31 |
| Reason classes | labeling |
| Lot numbers | 1707116 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0729-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.