Waldemar Link Recalls BiMobile UHMWPE Liners Due to Labeling Errors
Waldemar Link is recalling 31 BiMobile UHMWPE Liners because internal labels may contain incorrect part numbers, risking errors in patient records.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 minor labeling errors that could affect patient records, with no reported injuries or illnesses.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 31 units of the BiMobile UHMWPE Liner (ID-28mm/OD-54mm, Reference Number 184-260/04, Lot# 1707116). The recall is due to internal labeling that may include incorrect part numbers.
The affected devices are part of the LINK BiMobile Dual Mobility System, indicated for patients with mobility-limiting diseases, fractures, or defects. The devices are intended for cemented and cementless use. The incorrect labels could result in incorrect part numbers being added to patient records.
The devices were distributed in the United States to the states of Arizona, Florida, Georgia, Louisiana, Michigan, Minnesota, Texas, and Washington. Healthcare providers should verify the part numbers of implanted devices against the recall information and correct patient records if necessary.
The recalled product
- Product
- 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…
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Hazard
- Affected units
- 31
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# 1707116
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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