Recall Z-1768-2022 ยท LYA Splint, Intranasal Septal
GELITA MEDICAL GMBH
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
| Date | Jul 27, 2022 |
| Status | Terminated |
| Reason | In routine bioburden testing, higher than acceptable levels of Endotoxins were observed. |
| Root cause | Under Investigation by firm |
| Action | The firm emailed a Field Safety Notice to the sole consignee, a distributor, on 07/27/2022, 08/11/2022 and 08/15/2022. The first letter explained the problem, hazard, and requested the return of the product. If the product was further distributed to notify customers. The second and third letters requested that the recalled articles be destroyed. |
| Quantity | 3596 boxes of 50 devices |
| Distribution | US Nationwide distribution in the state of Alabama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP Curamedical, BV, Apr 13, 2006 |