Recall Z-2033-2012 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Spine
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.
| Date | Jul 19, 2012 (initiated Jan 13, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 273 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.