Z-0729-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 23, 2019
- Initiation Date
- December 4, 2018
- Termination Date
- June 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
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.
Distribution Pattern
US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
Code Information
Lot# 1707116