22 results
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Sources: EU EUDAMED, US FDA
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Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code MAX·November 3, 2025
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H;
FDA Recall
Open, Classified
·Orthofix U.S. LLC·Product code MAX·November 3, 2025
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
FDA Recall
Terminated
·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code NJT·December 30, 2015
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Recall
Terminated
·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015
6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HWX·April 13, 2012
4.5MM 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
2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HWX·February 25, 2026
5.5MM 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
CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010
AADCO Rayshield Frame Mounted Overhead X-Ray Barrier; Models: E3051AR S-568, 60 x 80 cm Frame Mounted Barrier with Cut-out, E3051AS S-568HL, 60 x 80 cm Frame Mounted Barrier with Cut-out and lamp, E3051AT S-634, 30 x 40 cm Frame Mounted Barrier, E3051AW S-645S, 40 x 50 cm Frame Mounted Barrier, E3051AY S-634HL, 30 x 40 cm Frame Mounted Barrier with lamp, and E3051AZ S-645SHL, 40 x 50 cm Frame Mounted Barrier with lamp, AADCO Medical, Inc., Randolph, VT. 05060
FDA Recall
Terminated
·Aadco Medical Inc.·Product code IWX·November 1, 2007
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
FDA Recall
Terminated
·Zimmer Spine, Inc.·Product code HWX·May 21, 2004
8.5MM 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
TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HWX·May 3, 2013
2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
FDA Recall
Open, Classified
·Synthes (USA) Products LLC·Product code HWX·February 25, 2026
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