Signature Femoral Head 111-152-621Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09348215001926), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K121297); 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 18, 2026.

Recalls naming this device

1. Feb 2, 2018Class IITerminated

   This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.

   Z-0920-2018 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

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.

• MalfunctionFeb 2, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AS REPORTED TO SIGNATURE ORTHOPAEDICS BY DISTRIBUTOR: "THIS MORNING ONE OF OUR REPS OPENED A 32 (S) CERAMIC FEMORAL HEAD WITH LOT NUMBER 78560 BUT INSIDE WAS A 28 (S) FEMORAL HEAD INSTEAD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7236540 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121297. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2021 · Apr 20, 2021 · Terminated
  Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.