Arthrex® ABS-2016-01Recalls & reported problems
Arthrex, Inc. · BioSurge Kit with 2.5cc AlloSync Pure · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867319936), received between Dec 19, 2023 and Dec 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing1
- Defective Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Use of Device Problem; Use of Device Problem
ON 11/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060R ANGEL CENTRIFUGE WAS GIVING AN ERROR MESSAGE STATING THAT THE LID IS NOT CLOSED. THE MAGNET RESPONSIBLE FOR HOLDING THE LID CLOSED WAS DETACHED AND LATER REATTACHED, BUT THE ERROR CONTINUED TO BE GIVEN AND THE CENTRIFUGE COULD NOT BE USED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680549 ↗MalfunctionDec 12, 2024Defective Device; Defective Device
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060 ANGEL MACHINE CONTINUED TO GIVE MALFUNCTION ERRORS (THE BLACK ROTOR WILL NOT STAY SEATED AND KEEPS COMING LOOSE). THIS OCCURRED DURING A KNEE SCOPE WITH INJECTION7, PREVENTING THEM FROM BEING ABLE TO SPIN DOWN THE BMAC AND PROVIDE THE INTENDED INJECTION TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 04/24/2024 WHERE IT WAS STATED THAT AN ABS-2016-01 BIOSURGE KIT WITH 2.5CC ALLOSYNC WAS BEING UTILIZED DURING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 20913421 ↗MalfunctionDec 19, 2023Component Missing; Component Missing
ON 11/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), THAT AN ABS-2016-01 BIOSURGE KIT USUALLY COMES WITH 2.5 CC OF BONE AND THIS KIT ONLY CARRIED 0.5 CC OF BONE. THIS OCCURRED DURING A CASE WHERE NO PATIENT WAS EFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360338 ↗
Other Platelet and plasma separator for bone graft handling devices
- Arthrex® ABS-10061TArthrex, Inc. · Platelet and plasma separator for bone graft handling75 reports
- Arthrex® ABS-10060RArthrex, Inc. · Platelet and plasma separator for bone graft handling66 reports
- Arthrex® ABS-10060Arthrex, Inc. · Platelet and plasma separator for bone graft handling59 reports
- Arthrex® ABS-10011Arthrex, Inc. · Platelet and plasma separator for bone graft handling51 reports
- Arthrex® ABS-10063Arthrex, Inc. · Platelet and plasma separator for bone graft handling49 reports
- Arthrex® ABS-10062TArthrex, Inc. · Platelet and plasma separator for bone graft handling35 reports
- Arthrex® ABS-10080Arthrex, Inc. · Platelet and plasma separator for bone graft handling9 reports
- Arthrex® ABS-2016-02Arthrex, Inc. · Platelet and plasma separator for bone graft handling7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.