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.
Reported: January 23, 2019 Initiated: December 4, 2018 #Z-0729-2019
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.
Details
- Recalling Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Units Affected
- 31
- Distribution
- US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
- Location
- Norderstedt
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site). Units affected: 31.
Why was this product recalled? ▼
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0729-2019.
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