Spinal Specialties, Inc Gertie Marx PainPak, Lot number 0504305, Reorder number 4060 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gertie Marx PainPak, Lot number 0504305, Reorder number 4060
Brand
Spinal Specialties, Inc
Lot Codes / Batch Numbers
Lot 0504305
Products Sold
Lot 0504305
Spinal Specialties, Inc is recalling Gertie Marx PainPak, Lot number 0504305, Reorder number 4060 due to Kit contains lidocaine, which has particulate matter in its ampule.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kit contains lidocaine, which has particulate matter in its ampule.
Recommended Action
Per FDA guidance
Firm notified consignees who received the product by telephone on 6/18/2004, then sent a letter via facsimile and next day air delivery.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MI, TX
Page updated: Jan 10, 2026