Revolution External Plating System 900217Recalls & 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.

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. Jun 8, 2020Completed

   1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.

   Z-1236-2022 · 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-1649-2022 · Dec 28, 2020 · Open, Classified
  Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Dril
• 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