CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report
Expedium Spine System/Synapse System recalled by DePuy Spine
DePuy Spine is recalling Expedium Spine System/Synapse System, distributed in Pennsylvania. The recall was initiated on 21 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1674-2015
- FDA event ID
- 71067
- Recalling firm
- DePuy Spine, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Apr 2015
- FDA classified
- 26 May 2015
- Reported
- 3 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 21 Apr 2015 | Recall initiated by company | |
| 26 May 2015 | Classified by FDA | +35 days |
| 3 Jun 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device does not mate as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Where it was distributed
US: PA and OUS: SE, BE, IT, PT
Questions about this recall
Why was it recalled?
Device does not mate as intended.
Which lots are affected?
LOT NUMBER: ARNDC6 & ARN DC7
Where was it sold?
US: PA and OUS: SE, BE, IT, PT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DePuy Spine
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EIT CIF cage, H, 8degree, L- an intervertebral body fusion recalled | DePuy Spine | Packaging Defects | Nationwide |
| Device | CLASS II | EIT CIF cage, H, 8degree, S- an intervertebral body fusion recalled | DePuy Spine | Packaging Defects | Nationwide |
| Device | CLASS II | Concorde Lift, Lordotic Expandable Interbody Device recalled | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Concorde Lift, Expandable Interbody Device recalled by DePuy Spine | DePuy Spine | Other | Nationwide |
| Device | CLASS II | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 recalled | DePuy Spine | Other | MA |
Other Spinal Implants recalls
All 1,161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline surgical convenience kits labeled as: Spinal CDS recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline surgical convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |