Instrument, Compression
FDA adverse event reports and recall history for instrument, compression (product code HWN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 808
- Deaths
- 0
- Injuries
- 26
- Malfunctions
- 779
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
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Offset Clamp Tips Inline, Item # 00-1179-028-01, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item # 00-1179-028-02, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
- 2010-12-01TerminatedNonconforming Material/Component
Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.
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