28 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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7.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code HWX·April 21, 2010
Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Sterilmed Inc·Product code HWX·August 8, 2008
CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Recall
Terminated
·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWX·April 8, 2019
CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010
Medacta AMIS Universal Table for Leg Positioner, Model Number: 01.15.10.0172. The AMIS universal table for leg positioner and AMIS Leg Positioner are used during Anterior Minimally Invasive Surgery for hip arthroplasty. The system aids the surgical procedure by providing support and alignment of the limb.
FDA Recall
Terminated
·Medacta Usa Inc·Product code FWX·May 21, 2008
CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010
6.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code HWX·April 21, 2010
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
FDA Recall
Open, Classified
·MAX LUX CORP 03e 01 01 Yangxi Indust Ry Zone Yangjiangyangjiang China·Product code RHP·October 26, 2021