Home / Recalls / DePuy Spine, Inc. / Z-1226-2019

Z-1226-2019 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, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)

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-1225-2019 Class II — Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (1 (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)