Medical Device Recall: 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 rev
Waldemar Link GmbH & Co. KG (Mfg Site) · December 5, 2024
Reason for Recall
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 Description
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.
Distribution
US Nationwide distribution in the states of AL, FL.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0769-2025
Status: ongoing
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