Drug recall
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿…
FDA recall event 95933 · Class II · Waldemar Link GmbH & Co. KG (Mfg Site)
Key facts
| Event ID | 95933 |
|---|---|
| Recall numbers | Z-0769-2025 |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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). |
| Initiation date | Dec 5, 2024 |
| Report date | Jan 1, 2025 |
| City | Norderstedt |
| Country | Germany |
| FEI number | 3003386935 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: