Skip to content

LINK InstrumentRecalls & reported problems across all models

WALDEMAR LINK GmbH & Co. KG · 14 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

12 open recalls name at least one LINK Instrument model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
8
Deaths reported
0
Injuries reported
0
Recalls
12

We found 14 models of LINK Instrument by WALDEMAR LINK GmbH & Co. KG in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2023 and Aug 29, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

12 FDA recall records name at least one of these models by its device identifier, 12 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

LINK Instrument recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2356-2023 · Root cause: Device Design · Recall details · FDA record ↗

  2. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2355-2023 · Root cause: Device Design · Recall details · FDA record ↗

  3. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2354-2023 · Root cause: Device Design · Recall details · FDA record ↗

  4. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2353-2023 · Root cause: Device Design · Recall details · FDA record ↗

  5. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2352-2023 · Root cause: Device Design · Recall details · FDA record ↗

  6. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2351-2023 · Root cause: Device Design · Recall details · FDA record ↗

  7. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2350-2023 · Root cause: Device Design · Recall details · FDA record ↗

  8. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2349-2023 · Root cause: Device Design · Recall details · FDA record ↗

  9. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2348-2023 · Root cause: Device Design · Recall details · FDA record ↗

  10. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2347-2023 · Root cause: Device Design · Recall details · FDA record ↗

  11. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2346-2023 · Root cause: Device Design · Recall details · FDA record ↗

  12. Jul 3, 2023Open, Classified

    Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue

    Z-2345-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported LINK Instrument problems

Device problems

  • Mechanical Jam4
  • Difficult or Delayed Separation2
  • Fracture2
  • Material Fragmentation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions8

LINK Instrument models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

Recent LINK Instrument adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

Other WALDEMAR LINK GmbH & Co. KG products

All WALDEMAR LINK GmbH & Co. KG devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page