Z-1960-2009

Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas...

Name: Z-1960-2009 Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas...
Creator: Stryker Spine
Published: 2006-06-14
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-06-14 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics... on 2006-06-14. The reason FDA records is "Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used". 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-1960-2009
Status: Terminated
Initiated: 2006-06-14
Posted: 2009-08-20
Terminated: 2009-08-20
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ 07430.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.
Quantity in commerce: 108572 total self drilling and self tapping.
Distribution: Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
Product codes and lots: All Product with the following Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diamter 4.5 x 20 mm.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)