Home / Recalls / OrthoPediatrics Corp / Z-2321-2017

Z-2321-2017 Class II Terminated

Recalled by OrthoPediatrics Corp — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
June 14, 2017
Initiation Date
April 24, 2017
Termination Date
September 18, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82

Product Description

Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.

Reason for Recall

Over-tensioning of the band resulting in damage to the band causing it to rupture

Distribution Pattern

Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

Code Information

All lots Product Number: 01-1102-1000

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  • 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)
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  • Z-0218-2020 Class II — Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric (August 19, 2019)
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  • 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-0879-2017 Class III — OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Sc (November 18, 2016)