Direct Inject recallZ-1436-2021 · Stryker Leibinger GmbH & Co. KG · initiated Apr 1, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Leibinger GmbH & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inability for the user to inject the paste from the syringe into the target location.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1436-2021
- Status
- Terminated
- Initiated by the company
- Apr 1, 2021
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 321 units
- Product code
- GXP
- FDA submissions
- K143661
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Product description
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.
Code information (models, lots, serial numbers)
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Direct Inject 79-45905Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY1 recall7 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K143661 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Direct Inject 79-45910Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY7 reports
- Direct Inject 79-45903Stryker Leibinger GmbH & Co. KG · METHYL METHACRYLATE FOR CRANIOPLASTY2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page