Z-0728-2019 Class II Terminated
FDA device recall Z-0728-2019 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on Dec 4, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 5, 2020). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 23, 2019
- Initiation Date
- Dec 4, 2018
- Termination Date
- Jun 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
Product Description
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 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# 1707121
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0728-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026