[Recalled] 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

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Stryker Spine

• Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. — Class II
• AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ AR — Class II
• Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument. — Class II
• Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients. — Class II
• The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: S — Class II
• SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Screws, Rod to Rod Conn — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.