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,…

Recall date

December 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0769-2025

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Sold / distributed

US Nationwide distribution in the states of AL, FL.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.