Arthrex® AR-13110L-01Recalls & reported problems
Arthrex, Inc. · CONTURLK FEM OSTEO PLT LFT S/M · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867088276), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Collapse” (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.
Reports received per month
Most reported problems
Device problems
- Collapse1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Collapse; Collapse
ON 07/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-13110L-01 OSTEOTOMY PLATE ALL SCREWS BACKED OUT AND THE PLATE COLLAPSED. THIS OCCURRED AFTER USE IN A CASE AND THE PATIENT REQUIRES A REVISION. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2024 AND WAS COMPLETED SUCCESSFULLY USING A COMPETITOR OSTEOTOMY PLATE. NO FURTHER INJURY TO PATIENT.
Patient problems: Failure of Implant
MAUDE report 20014585 ↗
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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 13, 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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