MobileLink Acetabular Cup System recallZ-2641-2023 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jul 14, 2023
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
Product is labeled with incorrect offset.
FDA root cause category: Under Investigation by firm
What the company is doing
On July 17, 2023, firm notified consignees via email. Customers were advised to return the affected product to LinkBio. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Recall details
- Recall number
- Z-2641-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2023
- Posted by the FDA
- Sep 26, 2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 8 units
- Product code
- LPH
- FDA submissions
- K200607
- Distribution
- Domestic distribution to AL, NJ, NV.
Product description
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Code information (models, lots, serial numbers)
UDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MobileLink Acetabular Cup System 183-610/05WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 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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