VARIAX 40-20807SRecalls & reported problems
Stryker GmbH · Straight Plate · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540667809), received between Jan 13, 2021 and Jul 11, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
- Off-Label Use1
Patient problems
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2023Break; Fracture; Off-Label Use; Break; Fracture; Off-Label Use
AS REPORTED: "I HAVE JUST SUPPORTED A CASE IN WHICH A BROKEN VARIAX 2 STRAIGHT FIBULA PLATE (REF: 40-20807S LOT: L22271) WAS REMOVED FROM A PATIENTS ULNAR (THE IMPLANT WAS USED TO TREAT A 22A2 AO CLASSIFICATION FRACTURE, WHEN IT IS LICENSED TO TREAT A VARIATION OF 44 AO CLASSIFIED FRACTURES.). THE BROKEN PLATE HAS BEEN REPLACED BY A VARIAX 2 BROAD COMPRESSION PLATE (629548S). THIS REVISION SURGERY TOOK LASTED 1.5 HOURS."
Patient problems: Failure of Implant
MAUDE report 17298002 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "ON (B)(6) 2020, THE PATIENT UNDERWENT THE INITIAL OPERATION FOR FOREARM BONE TRUNK WITH VARIAX. DUE TO A NONUNION, THE PATIENT UNDERWENT REVISION SURGERY WITH OTHER COMPANY PRODUCT ON (B)(6) 2020. THE SURGEON REQUESTED TO INVESTIGATE WHETHER THERE WAS A PROBLEM WITH THE PRODUCT ITSELF."
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 11164377 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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