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

FDA device recall Z-2772-2015 · posted 2015-09-16 · Terminated

Recall details

Recalling firm

Orthovita, Inc., dBA Stryker Orthobiologics.

Reason for recall

Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KIH

Quantity affected

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

Date initiated

2015-08-20

Date posted

2015-09-16

Date terminated

2017-03-10

Location

Malvern, PA