FDA Device recall 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 m…
- FDA Device
- Class II
- terminated
- Published 2019-01-23
On 2019-01-23 the FDA classified a Class II recall of BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with m… by Waldemar Link And Kg Mfg Site, citing the internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0729-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-04 |
| Published | 2019-01-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | AZ, FL, GA, LA, MI, MN, TX, WA |
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
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Identifiers
| code_info | Lot# 1707116 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0729-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.