Recall Z-0828-2016— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2015-12-18, terminated 2016-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Reported jamming of the impaction handle when assembled to the Inserter guide at the threads..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-18
- Terminated
- 2016-08-01
- Firm location
- Allendale, NJ, United States
Product description
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.
Reason for recall
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
Data sourced from openFDA. This site is unofficial and independent of the FDA.