Z-1113-04

Gertie Marx PainPak, Lot number 0504305, Reorder number 4060

Name: Z-1113-04 Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
Creator: Spinal Specialties, Inc
Published: 2004-06-18
License: https://open.fda.gov/license/

Spinal Specialties, Inc. / initiated 2004-06-18 / Terminated

FDA source

Spinal Specialties, Inc began a recall of Gertie Marx PainPak, Lot number 0504305, Reorder number 4060 on 2004-06-18. The reason FDA records is "Kit contains lidocaine, which has particulate matter in its ampule". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1113-04
Status: Terminated
Initiated: 2004-06-18
Posted: 2004-07-20
Terminated: 2004-10-20
Recalling firm: Spinal Specialties, Inc.
Product: Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
Product code: LRO General Surgery Tray
Reason for recall: Kit contains lidocaine, which has particulate matter in its ampule.
FDA root cause: Other
Action: Firm notified consignees who received the product by telephone on 6/18/2004, then sent a letter via facsimile and next day air delivery.
Quantity in commerce: 60 units
Distribution: El Paso, Texas and Lansing, Michigan
Product codes and lots: Lot 0504305

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)