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Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm,
Recalled January 1, 2025 · FDA recall Z-0769-2025 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset). · FDA Class II
Units
3 units
Sold at
US Nationwide distribution in the states of AL, FL.
Description
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
Product
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur.
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →