Recall Z-0222-2016 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
| Date | Nov 5, 2015 (initiated Sep 8, 2015) |
| Status | Terminated |
| Reason | The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized. |
| Root cause | Process control |
| Action | Stryker Spine issued an "Urgent Product Removal Notifications /Customer Response Forms dated September 11, 2015. to all affected customers via Fed Ex priority overnight. The notification instructed customers on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were asked to examine their inventory and related hospital location inventories; and reconcile any UniVise Inserters with Catalog numbers and Lot numbers (referenced in the notification). Customers were asked to fax a copy |
| Quantity | 41 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.