Z-2772-2015Class II

Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate...

Name: Z-2772-2015 Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate...
Creator: Orthovita, Inc., dBA Stryker Orthobiologics.
Published: 2015-08-20
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2015-08-20 / Terminated / root cause: packaging

FDA source

Orthovita, Inc., dBA Stryker Orthobiologics. began a recall of Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone on 2015-08-20. FDA classified it as Class II and gives the reason as "Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2772-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-20
Posted: 2015-09-16
Terminated: 2017-03-10
Recalling firm: DSM Biomedical, Inc.
Product: Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Product code: KIH Dispenser, Cement
Reason for recall: Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Stryker Sent an Urgent Product Recall letter dated August 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Our records indicate that you have received the above referenced instruments. It is Stryker Orthobiologics responsibility as the manufacturer to ensure that customers who may have received these affected instruments also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 215-253-5020. We regret any inconvenience this action may cause you and if you have any questions, please contact Stryker Orthobiologics at 610-640-1775 x 5299.
Quantity in commerce: 9805
Distribution: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Product codes and lots: All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2772-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2772-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-16

Product code KIH

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)