Extractor
FDA adverse event reports and recall history for extractor (product code HWB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,474
- Deaths
- 0
- Injuries
- 242
- Malfunctions
- 3,228
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-05-01CompletedUnder Investigation by firm
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
- 2010-12-28TerminatedOther
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
- 2010-04-27TerminatedLabeling Change Control
Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.
Literature did not include the design change to a smaller cannulation diameter.
- TerminatedDevice Design
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
There is a potential for the connection screw of the stem extractor to break.
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