Hip Implant Component Mislabeled With Wrong Insert Type on Packaging
LINK BiMobile hip implant liners are being recalled because packaging incorrectly identifies the insert type as F instead of G. This labeling error could delay surgery or result in the wrong component being used.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II surgical implant with mislabeled packaging that could lead to the wrong component type being used during hip replacement surgery. Although no illnesses or injuries have been reported, the product presents a risk of harm due to incorrect labeling of a surgical device component.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling the LINK BiMobile Dual Mobility System E-Poly Liner (28mm Head, 70mm Shell, Item Number 184-280/12) due to mislabeled packaging. The packaging incorrectly identifies the insert type as F when the actual insert type is G.
This labeling error could result in a delay during surgery as medical personnel verify which insert type is actually in the package. Additionally, if the error goes unnoticed, the incorrect insert type could be used during hip replacement surgery, potentially leading to implant complications.
The recalled liners were distributed worldwide, including to facilities in Illinois, Indiana, Florida, Washington, Germany, and Switzerland. Lot numbers affected are 2334253 and 2325426. Healthcare facilities and surgeons using these products should verify the actual insert type matches the surgical plan before use. Patients who have already received implants from these lot numbers should consult their physician.
The recalled product
- Product
- LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
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 (2)
- UDI-DI: 04026575230747 Lot Numbers: 2334253
- 2325426
Distribution
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