FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. d.b.a. Integra Pain Management: 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.
- Recall number
- Z-2868-2016
- Recalling firm
- Integra LifeSciences Corp. d.b.a. 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.
- Status
- Terminated
- Initiated
- 2016-08-24
- Posted
- not on file
- Terminated
- 2016-12-19
- Reason
- 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
- 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
- 320 packages
- Distribution
- Distributed to CA.
- Lot, serial or model codes
- Lot Number affected: W1503532
- 510(k) numbers
- ["K943319"]
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- 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