EXPEDIUM Spine System/Synapse System recallZ-1674-2015 · DePuy Spine, Inc. · initiated Apr 21, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device does not mate as intended.
FDA root cause category: Process design
What the company is doing
Consignees were notified of the recall via letter sent by overnight shipment for delivery on April 23, 2015. The letter instructs distributors and customers to review their inventory and return any products with the listed lot number.
Recall details
- Recall number
- Z-1674-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 21, 2015
- Posted by the FDA
- May 26, 2015
- Recalling firm
- DePuy Spine, Inc.
- Quantity
- 183 devices
- Product code
- NKB
- FDA submissions
- K101070, K111136, K142460
- Distribution
- US: PA and OUS: SE, BE, IT, PT
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
Code information (models, lots, serial numbers)
LOT NUMBER: ARNDC6 & ARN DC7
Other devices under the same FDA submission
50 devices cleared under K101070, K111136, K142460 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- EXPEDIUM VIPER 196789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL72 reports
- EXPEDIUM TOP NOTCH 179771555Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation41 reports
- VIPER 186789480Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY19 reports
- EXPEDIUM VIPER 196789300Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis18 reports
- EXPEDIUM 186100001Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL16 reports
- EXPEDIUM SFX 189401406Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY15 reports
- VIPER 186788045Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation10 reports
- EXPEDIUM SFX 189401405Depuy Spine, LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease10 reports
- EXPEDIUM VIPER 196789600Depuy Spine, LLC · APPLIANCE, FIXATION, SPINAL INTERLAMINAL10 reports
- EXPEDIUM 179774555Depuy Spine, LLC · ORTHOSIS, SPINAL PEDICLE FIXATION9 reports
- VIPER 186789200Depuy Spine, LLC · Pedicle screw spinal system, adolescent idiopathic scoliosis8 reports
- VIPER 186789300Depuy Spine, LLC · Orthosis, spondylolisthesis spinal fixation2 deaths7 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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