Waldemar Link BiMobile UHMWPE Liner Recalled for Incorrect Internal Labeling
Waldemar Link is recalling 30 BiMobile UHMWPE Liners because internal labeling may contain incorrect part numbers, risking errors in patient records.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to labeling errors that could affect patient records rather than direct physical harm, fitting the 'minor labeling errors' criterion for a Moderate score.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 30 units of the BiMobile UHMWPE Liner (ID-28mm/OD-50mm, Reference Number 184-260/02, Lot# 1707121). The recall was initiated because the internal labeling included with these implants may contain incorrect part numbers.
The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures, or defects that cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use. The affected units were distributed in the United States to the states of Arizona, Florida, Georgia, Louisiana, Michigan, Minnesota, Texas, and Washington.
The primary risk associated with this recall is that incorrect labels may be added to patient records. No injuries or illnesses have been reported in the source text. Healthcare providers and patients should verify the part numbers of implanted devices against the recall information to ensure accurate medical documentation.
The recalled product
- 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 intend
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# 1707121
Distribution
Part of a larger recall action
This product is one of 2 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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