Z-0431-2013Class II

Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use...

Name: Z-0431-2013 Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use...
Creator: Stryker Orthobiologics, Inc.
Published: 2012-07-26
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2012-07-26 / Terminated / root cause: design

FDA source

Stryker Orthobiologics, Inc. began a recall of Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's... on 2012-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0431-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2012-11-22
Terminated: 2014-10-29
Recalling firm: DSM Biomedical, Inc.
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.
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
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
Root cause tag: design
FDA root 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
Product codes and lots: Part number 2113-0013, lot numbers T1203002, T1204005, and T1206001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0431-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0431-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-22

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)