Arthrex® AR-4550BCRecalls & reported problems
Arthrex, Inc. · BioComposite, Meniscal Root Repair Kit · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867307551), received between Apr 28, 2023 and Jul 4, 2024 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Failure to Capture1
- Unexpected Therapeutic Results1
Patient problems
- Foreign Body Reaction1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 4, 2024Break; Failure to Capture; Break; Failure to Capture
ON 06/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-4550BC IMPLANT SYSTEM MALFUNCTIONED WHEN PASSING THE SUTURE WITH KNEE SCORPION THROUGH THE MENISCUS THE SUTURE WOULD NOT CAPTURE ON THE TRAP DOOR. THIS OCCURRED DURING A MENISCAL REPAIR WHERE THEY TRIED TO FIRE THE SCORPION OUTSIDE OF THE PATIENT AND THE NEEDLE TIP BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 19674181 ↗InjuryApr 28, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results
ON 3/31/2023, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT IN (B)(6) 2022, A 4.75 BIO COMPOSITE SWIVELOCK WAS IMPLANTED DURING A MENISCUS REPAIR PROCEDURE. SINCE THEN, THE PATIENT HAS BEEN EXPERIENCING ADVERSE REACTIONS. NO FURTHER INFORMATION WAS REPORTED. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED BY THE PATIENT VIA PHONE. THE PATIENT BELIEVES THE IMPLANT IS CAUSING AUTOIMMUNE DISORDERS. THE PROCEDURE TOOK PLACE ON (B)(6) 2022.
Patient problems: Foreign Body Reaction
MAUDE report 16838831 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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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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