Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, 130 DEG 9MM X 180MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, 130 DEG 11MM X 180MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, 125 DEG 9MM X 180MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceZimmer Biomet, Inc.Class IIAffixus Hip Fracture Nail, 125 DEG 11MM X 180MM
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
- 2018-02-07FDA-DeviceStryker Medical Division of Stryker CorporationClass IIMA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
- 2018-02-07FDA-DeviceAlere San Diego, Inc.Class IITriage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies
The recalled lots have demonstrated unexpected false positive THC results.
- 2018-02-07FDA-DeviceMolnlycke Health Care, IncClass II9x15" Medium Utility Positioner with Cover
Products may not meet specifications due to possible presence of metal shavings.
- 2018-02-07FDA-DeviceMolnlycke Health Care, IncClass II7x10" Small Utility Positioner with Cover
Products may not meet specifications due to possible presence of metal shavings.
- 2018-02-07FDA-DeviceExactech, Inc.Class IIEquinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Potentially mislabeled.
- 2018-02-07FDA-DeviceExactech, Inc.Class IIEquinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Potentially mislabeled.
- 2018-02-07FDA-DeviceOrmco/SybronendoClass IIElements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
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