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.
- Company
- Stryker Spine
- Recall Initiated
- December 18, 2015
- Terminated
- August 1, 2016
- Recall Number
- Z-0828-2016
- Quantity
- 31 units
- Firm Location
- Allendale, NJ
Reason for Recall
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Distribution
Nationwide Distribution
Lot / Code Info
Lot #144933, 14D252, and 14D253.
Root Cause
Nonconforming Material/Component
Action Taken
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 number provided. Questions can be directed to Nabil Riaz - Regulatory Compliance Specialist, Regulatory Compliance & Quality Systems at Nabil.Riaz@Stryker.com.