Arthrex® AR-13200ST-11.0Recalls & reported problems
Arthrex, Inc. · PLT,TIB A/P SLPD OSTEO · Class 2 · Implant
Data updated Oct 18, 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 00888867009653), received between Feb 3, 2017 and Feb 3, 2017 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Break1
- Crack1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 3, 2017Break; Crack
IT WAS REPORTED BY THE PATIENT THAT HE HAS HAD A FEW REVISION SURGERIES DUE TO SCREWS AND PLATES BREAKING AFTER THE INITIAL KNEE OSTEOTOMY PROCEDURE. ADDITIONAL INFORMATION OBTAINED 1/13/2017 FROM THE SALES REP: PATIENT UNDERWENT A TIBIAL OSTOTOMY PROCEDURE ON (B)(6) 2016 DURING WHICH TIME THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: TIBIAL PLATE AR-13200ST-11.0 LOT 1188334 ((B)(4)), CANCELLOUS SCREW AR-13280-50 (ONE FROM EACH LOT) LOT 1188605 ((B)(4)) AND LOT 1216276 ((B)(4)), CORTICAL SCREW AR-13380-42 LOT 451550 ((B)(4)), CORTICAL SCREW AR-13380-48 LOT 411131 ((B)(4)), OSFERION OSTEO WEDGE AR-13370-3 LOT M13Z06B331 ((B)(4)), AND OSFERION OSTEO WEDGE (QTY 2) AR-13370-2 LOT M14114B344 ((B)(4)). POST SURGERY IT WAS DISCOVERED THAT THE PLATE HAD BROKEN AND ON (B)(6) 2016 THE PATIENT UNDERWENT A REVISION DURING AT WHICH TIME THE ARTHREX PRODUCTS WERE EXPLANTED. TO COMPLETE THE REVISION PROCEDURE THE SURGEON USED A BONE GRAFT WITH AN ANTIBIOTIC IMPREGNATED METHACRYLATE WEDGE. NO ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION. THE SURGEON HAD INFORMED THE SALES REP THAT SHE FELT THAT THE CRACKED PLATE MAY HAVE BEEN DUE TO PATIENT NON-COMPLIANCE. ARTHREX WAS ALSO INFORMED THAT TH
Patient problems: No Code Available
MAUDE report 6300547 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page