FDA Medical Device Recalls (openFDA)
Orthovita, Inc., dBA Stryker Orthobiologics.: Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
- Recall number
- Z-2772-2015
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- 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
- Status
- Terminated
- Initiated
- 2015-08-20
- Posted
- 2015-09-16
- Terminated
- 2017-03-10
- Reason
- Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
- 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
- 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.
- Lot, serial or model codes
- All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KIH
- Firm FEI
- 1000307073
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28