Home / Recalls / OrthoPediatrics Corp / Z-0622-2016

Z-0622-2016 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
January 20, 2016
Initiation Date
November 10, 2015
Termination Date
May 23, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102

Product Description

UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Reason for Recall

Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.

Distribution Pattern

US Distribution to states of: AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MO, MN, MS, NC, NJ, NY, OH, OR, TN, and TX.

Code Information

Item number; lot; product description 00-1300-1735; 44003; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 35MM. 00-1300-0735; 44601; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 35MM. 00-1300-0740; 44602; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 43926; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0740; 44252; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM. 00-1300-0745; 43927; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 45MM. 00-1300-0750; 44619; 5.5/6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 50MM. 00-1300-0620; 44623; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 20MM. 00-1300-0640; 44617; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-0640; 44884; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM. 00-1300-1745; 44005; 5.5/6.0 UNIAXIAL REDUCTION PEDICLE SCREW 7.0MM X 45MM. 00-1300-0635; 44677; 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 35MM.

Other recalls by OrthoPediatrics Corp

  • Z-0277-2023 Class II — Orthex Large Bone Shoulder Bolt, model no. AS-17 (September 12, 2022)
  • Z-1678-2022 Class II — Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN (June 29, 2022)
  • Z-2742-2020 Class II — Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spin (July 6, 2020)
  • Z-2539-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model (June 5, 2020)
  • Z-2538-2020 Class II — OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model (June 5, 2020)
  • Z-0218-2020 Class II — Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric (August 19, 2019)
  • Z-0219-2020 Class II — Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pedia (August 19, 2019)
  • Z-0125-2020 Class II — OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Plat (August 19, 2019)
  • Z-0597-2018 Class II — Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: P (August 3, 2017)
  • Z-2321-2017 Class II — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-11 (April 24, 2017)