Home / Recalls / DePuy Spine, Inc. / Z-1225-2019

Z-1225-2019 Class II Terminated

Recalled by DePuy Spine, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
May 8, 2019
Initiation Date
April 8, 2019
Termination Date
January 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3166 total

Product Description

Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)

Reason for Recall

A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.

Distribution Pattern

US Nationwide distribution. Foreign distribution to Austria, Switzerland, and United Kingdom.

Code Information

All lots

Other recalls by DePuy Spine, Inc.

  • Z-1323-2022 Class II — EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated (May 20, 2022)
  • Z-1324-2022 Class II — EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated (May 20, 2022)
  • Z-1226-2019 Class II — Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (April 8, 2019)
  • Z-1300-2018 Class II — Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10 (December 15, 2017)
  • Z-0624-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW (October 12, 2016)
  • Z-0625-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW (October 12, 2016)
  • Z-0628-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 (October 12, 2016)
  • Z-0627-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW (October 12, 2016)
  • Z-0626-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4 (October 12, 2016)
  • Z-0630-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4 (October 12, 2016)