Device 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.
Z-0729-2019
Product summary
- Event
- Event 81762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-0729-2019
Official wording
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.
Code information: Lot# 1707116
Distribution pattern: US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
Derived failure modes
-
Labeling or packaging
incorrect labels