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Recall Observatory FDA recall evidence

Device 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.

Z-1353-2015

February 26, 2015

Class II

Product summary

Firm
Orthovita, Inc., dBA Stryker Orthobiologics.
Event
Event 70609
Status
Terminated
Classification
Class II
Quantity
274
Official record key
device-enforcement:Z-1353-2015

Official wording

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.

Code information: 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

Distribution pattern: Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.