Recall Z-2033-2012
Stryker Spine · initiated January 13, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Class I; 510(k) Exempt Description: AVS¿ Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875.
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.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-2033-2012
- Initiated
- January 13, 2012
- Posted by FDA
- July 19, 2012
- Terminated
- July 29, 2013
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 273 units
- Distribution
- Nationwide.
- Recalling firm
- Stryker Spine, Allendale, NJ