LINK Instrument 136-101/46Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026575181957), received between Aug 10, 2023 and Aug 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K183141); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING THE SURGERY, THE SURGEON EXPERIENCED EXTREME DIFFICULTY IN REMOVING THE TRIAL STEM, SO MUCH SO THAT THE SURGEON WAS CONCERNED THAT AN OSTEOTOMY WOULD BE NEEDED. THE TRIAL WAS EVENTUALLY REMOVED. THIS ADDED APPROXIMATELY 15 MINUTES TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17496625 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183141. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2355-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 24 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2346-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item
• Z-2351-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 20 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2348-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2350-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Num
• Z-2347-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2353-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2345-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Nu
• Z-2352-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2354-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 23 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N
• Z-2349-2023 · Jul 3, 2023 · Open, Classified
  LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 18 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item N