REACH MODULAR HIP SYSTEM 21-108395Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K022463, K030055); 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. Aug 21, 2019Class IITerminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0523-2020 · Root cause: Environmental control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022463, K030055. One submission often covers many models, so check the product and lot details in each record.

• Z-1754-2015 · Apr 16, 2015 · Terminated
  Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral
• Z-1122-2015 · Jan 9, 2015 · Terminated
  Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)