Z-2868-2016Class II

PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals...

Name: Z-2868-2016 PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2016-08-24
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2016-08-24 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices... on 2016-08-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2868-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-24
Posted: 2016-09-21
Terminated: 2016-12-19
Recalling firm: Integra Pain Management
Product: 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.
Product code: CAZ Anesthesia Conduction Kit
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Consignees notified on 8/24/16 via an Urgent - Field Corrective Action letter e-mail. The letter identified the affected device and the reason for the recall. Customers were asked to review their inventory of the Spinal Tray 24 G Gertie Marx to confirm the quantity received. The attached form should be completed and returned by e-mail or fax as indicated. Once the form is received, Customer Service will place an order for the customer to receive replacement devices. Questions should be directed to Customer Service at 1-800-241-2210.
Quantity in commerce: 320 packages
Distribution: Distributed to CA.
Product codes and lots: Lot Number affected: W1503532

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2868-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2868-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

Product code CAZ

K943319Class IIGertie Marx Epi-Spinal TraySpinal Specialties, Inc. / cleared 1995-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)