Z-0217-2009

Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine...

Name: Z-0217-2009 Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine...
Creator: Stryker Spine
Published: 2008-08-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-08-18 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica... on 2008-08-18. The reason FDA records is "The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0217-2009
Status: Terminated
Initiated: 2008-08-18
Posted: 2008-11-20
Terminated: 2009-06-19
Recalling firm: Howmedica Osteonics Corp
Product: Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.
Quantity in commerce: 183 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot code: NSZ.

Product code KWQ

K040261Class IIReflex Hybrid Anterior Cervical Plate SystemStryker Spine / cleared 2004-04-16

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)