Z-1353-2015 Class II Terminated
FDA device recall Z-1353-2015 was initiated by Orthovita, Inc., dBA Stryker Orthobiologics. on February 26, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 28, 2015). Affected quantity: 274.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- February 26, 2015
- Termination Date
- July 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 274
Product Description
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 for Recall
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.
Distribution Pattern
Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
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