Arthrex® AR-8948W-2075Recalls & reported problems
Arthrex, Inc. · BioSync Anatomic Cotton Wedge, 20x7.5 mm · 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 00888867266803), received between Sep 19, 2022 and Sep 19, 2022 — 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
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2022Break; Entrapment of Device
IT WAS REPORTED ON 09/01/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8948W-2075 BIOSYNC WEDGE BROKE IN THE PATIENT REQUIRING A REVISION SURGERY TO REMOVE.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 15445778 ↗
Other Bone Wedge devices
- Arthrex® AR-8948W-1665Arthrex, Inc. · Bone Wedge2 recalls0 reports
- Arthrex® AR-8948W-2045Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-2065Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-1645Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-2055Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8942W-1806Arthrex, Inc. · Bone Wedge1 report
- Arthrex® AR-8942W-2006Arthrex, Inc. · Bone Wedge1 report
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.
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