Arthrex® AR-1926BRecalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, BIO-PUSHLOCK · 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 00888867023215), received between Nov 9, 2020 and Nov 9, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, BY AN INFECTIOUS DISEASE PHYSICIAN, THAT A PATIENT HAD UNDERGONE A SHOULDER PROCEDURE (B)(6) 2019. PATIENT BEGAN HAVING ISSUES WITHIN A FEW WEEKS POST SHOULDER SURGERY AND HAS BEEN DIAGNOSED WITH EARLY ONSET RECURRING SHOULDER INFECTION. CULTURES CONFIRMED T-ACNES AND PATIENT HAS BEEN TREATED DURING LAST YEAR WITH ONGOING SUPPRESSIVE ANTIBIOTICS. NO DECISION HAS BEEN MADE AT THIS TIME TO EXPLANT THE DEVICES. THE FOLLOWING ARE THE PATIENT'S IMPLANTS: AR-1927BFT, BIO-CORKSCREW FT, LOT 10218944 (QTY 1) AND LOT 10302639 (QTY 1), AR-1926B. BIO-PUSHLOCK, LOT 10298187 (QTY 2).
Patient problems: Unspecified Infection
MAUDE report 10808379 ↗
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- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
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- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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