Arthrex® AR-8948W-1645Recalls & reported problems
Arthrex, Inc. · BioSync Anatomic Cotton Wedge, 16x4.5 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Apr 22, 2016Class IITerminated
Potential for polystyrene particulate presence.
Z-1958-2016 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
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-2055Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8942W-1806Arthrex, Inc. · Bone Wedge1 report
- Arthrex® AR-8942W-2006Arthrex, Inc. · Bone Wedge1 report
- Arthrex® AR-8948W-2075Arthrex, 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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