Home / Recalls / DePuy Spine, Inc. / Z-1674-2015

Z-1674-2015 Class II Terminated

Recalled by DePuy Spine, Inc. — Raynham, MA

Recall Details

Product Type
Devices
Report Date
June 3, 2015
Initiation Date
April 21, 2015
Termination Date
October 3, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
183 devices

Product Description

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

Reason for Recall

Device does not mate as intended.

Distribution Pattern

US: PA and OUS: SE, BE, IT, PT

Code Information

LOT NUMBER: ARNDC6 & ARN DC7

Other recalls by DePuy Spine, Inc.

  • Z-1324-2022 Class II — EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated (May 20, 2022)
  • Z-1323-2022 Class II — EIT CIF cage, H 6mm, 8degree, L- 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-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-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)
  • 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-0629-2017 Class II — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCR (October 12, 2016)