Recall Z-0828-2016 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
| Date | Dec 18, 2015 |
| Status | Terminated |
| Reason | Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker Spine sent Urgent Product Removal notification letters to branches/agencies on 12/18/2015 via FedEx. The letters provided a description of the affected product, the issue, potential hazards and risk mitigations, and actions to be taken. Customers were asked to examine their inventory and hospital locations to identify the product and reconcile with the affected catalog and lot numbers provided. The Customer Response Form and Product Quantity Tracking Spreadsheet for Health Care Facilities should be completed and returned within five days of receipt of the notice to the e-mail or fax |
| Quantity | 31 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.