Hallux Osteotomy Plate 21015-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09120047298664), received between Jun 27, 2017 and Jan 27, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K131722); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2022Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT THE LOCKING SCREW PASSED THE PLATE HOLE APPROX. 1-1,5 MONTHS POST-OP.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13364790 ↗
• MalfunctionJan 9, 2019Accessory Incompatible; Defective Component; Accessory Incompatible; Defective Component

  IT WAS REPORTED THAT THE HALLUX OSTEOTOMY PLATE COULDN'T BE MOUNTED ON THE INSERTION GUIDE. THE INCIDENT DIDN'T HAPPEN DURING SURGERY.

  Patient problems: No Information

  MAUDE report 8230298 ↗
• MalfunctionJun 27, 2017Device Issue; Device Issue

  CONCERNING THE COMPLAINT FORM WE HAVE RECEIVED FROM OUR DISTRIBUTOR, A D=3.0MM CANCELLOUS SCREW HAS NOT LOCKED IN A HALLUX OSTEOTOMY PLATE. DUE TO THIS ANOTHER SCREW WAS USED TO FINISH THE SURGERY.

  Patient problems: Missing Value Reason

  MAUDE report 6669551 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131722. One submission often covers many models, so check the product and lot details in each record.

• Z-1606-2026 · Jan 23, 2026 · Open, Classified
  HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31
• Z-1605-2026 · Jan 23, 2026 · Open, Classified
  FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Canc