MALLORY/HEAD CALCAR HIP SYSTEM 11-104973Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304200500), received between Oct 22, 2019 and Oct 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K031693); 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.

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.

• MalfunctionOct 22, 2019Packaging Problem; Packaging Problem

  IT WAS DETERMINED THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A REPORTABLE MALFUNCTION, SERIOUS INJURY, OR ADVERSE EVENT. PLEASE VOID THIS SUBMISSION.

  Patient problems: No Patient Involvement

  MAUDE report 9217763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031693. One submission often covers many models, so check the product and lot details in each record.

• Z-0622-2021 · Nov 25, 2020 · Terminated
  M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
• Z-1679-2010 · Mar 10, 2010 · Terminated
  19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm lt.., Sterile, REF CP154604, Biomet Orthopaedics, Warsaw, IN. Implant device inte
• Z-1678-2010 · Mar 10, 2010 · Terminated
  19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm rt., Sterile, REF CP154599, Biomet Orthopaedics, Warsaw, IN. Implant device inten
• Z-1667-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, REF 11-104902, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in fe
• Z-1669-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile, REF 11-104905, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use i
• Z-1674-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104971, Biomet Orthopaedics, Warsaw, IN. Implant device intended fo
• Z-1671-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, Sterile, REF 11-104947, Biomet Orthopaedics, Warsaw, IN. Implant device intended for
• Z-1675-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Sterile, REF 11-104972, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use
• Z-1672-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953, Biomet Orthopaedics, Warsaw, IN. Implant device intended for
• Z-1665-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor
• Z-1676-2010 · Mar 10, 2010 · Terminated
  17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF CP154591, Biomet Orthopaedics, Warsaw, IN. Implant device intended
• Z-1668-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 11-104904, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor
• Z-1677-2010 · Mar 10, 2010 · Terminated
  17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 mm rt., Sterile, REF CP154593, Biomet Orthopaedics, Warsaw, IN. Implant device inten
• Z-1673-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, Sterile, REF 11-104954, Biomet Orthopaedics, Warsaw, IN. Implant device intended for
• Z-1670-2010 · Mar 10, 2010 · Terminated
  Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN. Implant device intended for u

…and 1 more.