Recall Z-1515-06 ยท LYA Splint, Intranasal Septal
Porex Surgical, Inc.
Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
| Date | Sep 22, 2006 (initiated Jul 11, 2006) |
| Status | Terminated |
| Reason | Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material |
| Root cause | Other |
| Action | Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.