Class 2 Device Recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat

• Date Initiated by Firm: July 26, 2012
• Date Posted: November 22, 2012
• Recall Status: Terminated on October 29, 2014
• Recall Number: Z-0431-2013
• Recall Event ID: 62834
• PMA Number: P050044
• Product Classification: Agent, absorbable hemostatic, collagen based - Product Code LMF
• Product: Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
• Code Information: Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.
• FEI Number: 1000307073
• Recalling Firm/ Manufacturer: Stryker Orthobiologics, Inc.; 45 Great Valley Pkwy; Malvern PA 19355-1302
• For Additional Information Contact: Customer Support; 610-640-1775
• Manufacturer Reason for Recall: When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
• FDA Determined Cause: Device Design
• Action: Stryker sent a "MEDICAL DEVICE FIELD CORRECTION" dated July 26, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter included a Business Reply Form for customers to complete and return via fax to 1-484-323-8803. Contact the firm at 1-888-774-8870 for questions regarding this notice.
• Quantity in Commerce: 3,268
• Distribution: Nationwide Distribution-including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, SD, TN, TX, VA, WA, WI, and WV
• Total Product Life Cycle: TPLC 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.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LMF