Recall Z-1436-2021 ยท GXP Methyl Methacrylate For Cranioplasty
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.
| Date | Apr 1, 2021 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143661 | DirectInject Stryker, Sep 2, 2015 |