Z-2033-2012Class II

Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France...

Name: Z-2033-2012 Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France...
Creator: Stryker Spine
Published: 2012-01-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-01-13 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of 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... on 2012-01-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2033-2012
Classification: Class II
Status: Terminated
Initiated: 2012-01-13
Posted: 2012-07-19
Terminated: 2013-07-29
Recalling firm: Howmedica Osteonics Corp
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA 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 in commerce: 273 units
Distribution: Nationwide.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2033-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2033-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-25	2012-07-19

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)