28 results
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14ms
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Sources: EU EUDAMED, US FDA
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
FDA Recall
Terminated
·Polymer Technology Systems, Inc.·Product code NBW·March 15, 2016
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
FDA Recall
Terminated
·Product code HRS·January 11, 2016
Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
FDA Recall
Terminated
·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code LXH·August 12, 2011
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
FDA Recall
Terminated
·OrthoPediatrics Corp·Product code HWC·July 24, 2013
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
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
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
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
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
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code ELR·August 21, 2018
Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWT·March 13, 2008
LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code HWC·September 15, 2009
LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code HWC·September 15, 2009
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Recall
Terminated
·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·July 5, 2018
DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Recall
Terminated
·Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany·Product code HBL·July 5, 2018
IMRIS MR/X-ray head fixation device, Model HFD200
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code HBL·June 26, 2019
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HBL·November 11, 2020
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code HBL·February 17, 2022
MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code HBL·June 29, 2004