Revolution External Plating System 620080Recalls & 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, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K181630); 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. Dec 28, 2020Open, Classified

   Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

   Z-1649-2022 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181630. One submission often covers many models, so check the product and lot details in each record.

• Z-1236-2022 · Jun 8, 2020 · Completed
  1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
• Z-0318-2020 · Oct 10, 2019 · Terminated
  Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636 00151504836 00151505040 00151505240 00151505444 00151505644 00151505848 00151506048 00151506248
• Z-1280-2022 · Aug 14, 2019 · Open, Classified
  Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
• Z-1824-2023 · Jul 23, 2019 · Open, Classified
  'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805