Recall Z-0728-2019— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Terminated
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2018-12-04, terminated 2020-06-05. It names one FDA 510(k) clearance: K171273. Product: 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: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-04
- Terminated
- 2020-06-05
- Firm location
- Norderstedt, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.