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COMPRESS DEVICE 178786Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K112905, K123297, K173411); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Aug 21, 2019Terminated

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

    Z-0519-2020 · Root cause: Environmental control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112905, K123297, K173411. One submission often covers many models, so check the product and lot details in each record.

  • Z-0642-2019 · Oct 12, 2018 · Terminated
    Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Devi

Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.