BiMobile recallZ-1219-2024 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jan 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
FDA root cause category: Under Investigation by firm
What the company is doing
LinkBio Corp issued Urgent: Medical Device Recall letter via email on 1/22/24 to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Recall details
- Recall number
- Z-1219-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 22, 2024
- Posted by the FDA
- Feb 29, 2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product code
- LZO
- FDA submissions
- K190535
- Distribution
- Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BiMobile 184-280/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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