FDA Device recall Z-1353-2015
Vitagel
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Vitagel by Orthovita, citing several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1353-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-26 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthovita |
| Distribution | US |
Product
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Reason
Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
Identifiers
| code_info | Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A14…Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1353-2015%22
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