FDA Medical Device Recalls (openFDA)
Stryker Leibinger GmbH & Co. KG: DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
- Recall number
- Z-1436-2021
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
- Status
- Terminated
- Initiated
- 2021-04-01
- Posted
- not on file
- Terminated
- 2022-12-19
- Reason
- Inability for the user to inject the paste from the syringe into the target location.
- Root cause
- Under Investigation by firm
- Action
- On 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
- Quantity
- 321 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
- Lot, serial or model codes
- Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
- 510(k) numbers
- ["K143661"]
- PMA numbers
- not on file
- Product code
- GXP
- Firm FEI
- 3002821504
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
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