FDA Medical Device Recalls (openFDA)
Spinal Specialties, Inc: Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
- Recall number
- Z-1113-04
- Recalling firm
- Spinal Specialties, Inc
- Product
- Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
- Status
- Terminated
- Initiated
- 2004-06-18
- Posted
- 2004-07-20
- Terminated
- 2004-10-20
- Reason
- Kit contains lidocaine, which has particulate matter in its ampule.
- 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
- 60 units
- Distribution
- El Paso, Texas and Lansing, Michigan
- Lot, serial or model codes
- Lot 0504305
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1000306134
- Firm city
- San Antonio
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28