Recall Z-2536-2016 · NDN Cement, Bone, Vertebroplasty
Stryker Instruments Div. of Stryker Corporation
Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly
| Date | Aug 15, 2016 (initiated Jun 14, 2016) |
| Status | Terminated |
| Reason | The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for the injection procedure. |
| Root cause | Process control |
| Action | On 6/13/2016, URGENT MEDICAL DEVICE RECALL NOTIFICATION notifications were sent to the affected customers via courier and sales representatives via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Jennifer Olson 269-389-2644 jennifer.olson@stryker.com |
| Quantity | 4,841 boxes (9,682 units) |
| Distribution | Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement Stryker Corporation, Jun 12, 2015 |