FDADecember 5, 2024device
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 reconstruc...
Official recall recorded by the U.S. Food & Drug Administration.
The 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).
What to do
FDA enforcement status: Ongoing
Brands named
waldemar link gmbh co kg mfg sitewaldemarwaldemar link
UPCs
04026575409785
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPediatric care bed; Product Designation: KayserBett IDA;2026-05-04
- FDABrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction w...2026-04-16
- FDAHeraeus, PALAMIX duo. Material Number: 66057897.2026-03-25
- FDAHeraeus, PALAMIX uno. Material Number: 66057893.2026-03-25
- FDAEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;2026-02-11
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
- FDAEndo-Model Replacement Plateau; Item Number: 15-2835/12;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;2026-01-12
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