Z-1515-06

Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA

Name: Z-1515-06 Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA
Creator: Porex Surgical, Inc.
Published: 2006-07-11
License: https://open.fda.gov/license/

Porex Surgical, Inc. / initiated 2006-07-11 / Terminated

FDA source

Porex Surgical, Inc. began a recall of Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA on 2006-07-11. The reason FDA records is "Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1515-06
Status: Terminated
Initiated: 2006-07-11
Posted: 2006-09-22
Terminated: 2007-02-06
Recalling firm: Porex Surgical, Inc.
Product: Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
Product code: LYA Splint, Intranasal Septal
Reason for recall: Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material
FDA root cause: Other
Action: Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.
Quantity in commerce: 27 units
Distribution: Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany
Product codes and lots: Catalog number 7241-Lot number B002E05N

Product code LYA

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)