Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.
FDA device recall Z-2033-2012 · posted 2012-07-19 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- 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.
- Action taken
- Stryker sent an "URGENT PRODUCT RECALL" letter to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was included for customers to complete and return via fax to Regulatory Compliance at 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 273 units
- Distribution
- Nationwide.
- Date initiated
- 2012-01-13
- Date posted
- 2012-07-19
- Date terminated
- 2013-07-29
- Location
- Allendale, NJ
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