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U.S. Department of Health and Human Services

Class 2 Device Recall ORCA FOAM STANDARD CUBE

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 Class 2 Device Recall ORCA FOAM STANDARD CUBEsee related information
Date Initiated by FirmJuly 27, 2022
Create DateSeptember 19, 2022
Recall Status1 Completed
Recall NumberZ-1768-2022
Recall Event ID 90743
510(K)NumberK060878 
Product Classification Splint, intranasal septal - Product Code LYA
ProductORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
Code Information UDI/DI 00860003109915, Batch Numbers: T02371/1, expiration date 10.02.2026; T02371/2, expiration date 10.02.2026; T02395/1, expiration date 07.05.2026; T02394/2, expiration date 07.05.2026
Recalling Firm/
Manufacturer		 GELITA MEDICAL GMBH
Uferstr. 7
Eberbach Germany
For Additional Information Contact
496271842021
Manufacturer Reason
for Recall		In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 in Commerce3596 boxes of 50 devices
DistributionUS Nationwide distribution in the state of Alabama.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = LYA
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