Stryker AutoPlex System. Model Numbers 0607-687-000, 0605-887-000, 0605-687-000, and 0605-683-000. For bone cement. Stry
FDA device recall Z-2536-2016 · posted 2016-08-15 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- NDN
- Quantity affected
- 4,841 boxes (9,682 units)
- Distribution
- Worldwide distribution. US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.
- Date initiated
- 2016-06-14
- Date posted
- 2016-08-15
- Date terminated
- 2017-03-27
- Location
- Portage, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vertaplex® High Viscosity (HV) Radiopaque Bone Cement (K150582) | Stryker Corporation | 2015-06-12 |