Viper 186715955

• 7 recalls, same reason

  • Terminated Z-0706-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0705-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0708-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0712-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0709-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0707-2013 FDA Class II ·initiated 7 Nov 2012
  • Terminated Z-0710-2013 FDA Class II ·initiated 7 Nov 2012

  Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

• • Terminated Z-0713-2013 FDA Class II ·initiated 7 Nov 2012

  Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

Trade Name

Viper

Generic Name

Spinal bone screw, non-bioabsorbable

Model / Ref / Catalog

186715955

Primary DI / UDI-DI

10705034122984

510(k) Number

K101993 ↗

FDA Product Code

MNI, KWP, KWQ, NKB, MNH

GMDN Term

Spinal bone screw, non-bioabsorbable

Device Class

Class II

Regulation Number

888.3070, 888.3050, 888.3060

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

Category: Spinal bone screw, non-bioabsorbable

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