Stryker Spine: Medical Device Recall in 2012 - (Recall #: Z-2033-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 13, 2012

Date Posted: July 25, 2012

Recall Number: Z-2033-2012

Event ID: 61723

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.

Status: Terminated

Product Quantity: 273 units

Code Information:

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.

Distribution Pattern:

Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated