CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
PHS Spinal Tray Gertie Marx recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling PHS Spinal Tray Gertie Marx, distributed in California. The recall was initiated on 24 Aug 2016 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-2868-2016
- FDA event ID
- 75029
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2016
- FDA classified
- 21 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 24 Aug 2016 | Recall initiated by company | |
| 21 Sep 2016 | Classified by FDA | +28 days |
| 28 Sep 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
Product as listed by the FDA
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
Where it was distributed
Distributed to CA.
Questions about this recall
Is PHS Spinal Tray Gertie Marx recalled?
Yes. Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled PHS Spinal Tray Gertie Marx on 24 Aug 2016. The recall is Class II and its status is Terminated. Recall number Z-2868-2016.
Why was it recalled?
Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
Which lots are affected?
Lot Number affected: W1503532
Where was it sold?
Distributed to CA.
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 21 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 Integra LifeSciences Corp. d.b.a. Integra Pain Management
All 10Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |