Recall Z-2033-2012— Stryker Spine
Class II · Terminated
Class II FDA medical device recall by Stryker Spine, initiated 2012-01-13, terminated 2013-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.. Reason: Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head..
- Recalling firm
- Stryker Spine
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-01-13
- Terminated
- 2013-07-29
- Firm location
- Allendale, NJ, United States
Product description
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively.
Reason for recall
Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
Data sourced from openFDA. This site is unofficial and independent of the FDA.