Arthrex® ABS-2000-CTRecalls & reported problems
Arthrex, Inc. · IOBP KNEE CLOSED TIP PROCEDURE KIT · Class 2
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 00888867337312), received between Apr 18, 2023 and Apr 18, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2023Use of Device Problem; Use of Device Problem
ON (B)(6) 2023, A CLINDEX NOTIFICATION INDICATED THAT A SEVERE COMPLICATION OCCURRED TO A PATIENT LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY. THIS EVENT WAS INITIALLY INDICATED AS PROBABLY RELATED TO THE INTRAOSSEOUS BIOPLASTY PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE INCREASED TORQUE ON THE DRILL CAUSED A 3CM BY 0.5CM WAFTER FEMORAL CONDYLE FRACTURE LATERALLY. AN ABS-2000-CT INTRAOSSEOUS BIOPLASTY CORE DECOMPRESSION DELIVERY KIT WAS USED AS AN ABS-2010-05 ALLOSYNC PURE AND A ABS-10062T ANGEL CPRP SYSTEM WITH ASPIRATION KIT. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023: THIS OCCURRED DURING AN LOBP FEMORAL CONDYLE. THE FRACTURE WAS NOT REPAIRED, AND THE PATIENT WAS MONITORED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 16761947 ↗
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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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