Recall Z-0769-2025— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2024-12-05. It names one FDA 510(k) clearance: K142187. 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.. Reason: 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)..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-05
- Firm location
- Norderstedt, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.