Recall archive / FDA device enforcement
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Incl... — FDA record Z-2641-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 14, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
- Reason
- Product is labeled with incorrect offset.
- Classification
- Class II
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 8 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2641-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to AL, NJ, NV.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 4, 2023
- Recall initiation date
- Jul 14, 2023
- Center classification date
- Sep 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.