Stryker Spine Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430.
Brand
Stryker Spine
Lot Codes / Batch Numbers
All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm, 48664012, diameter 4.0 x 12 mm, 48604014, diameter 4.0 x 14 mm, 48664016, diameter 4.0 x 16 mm, 48664018, diameter 4.0 x 18 mm.
Products Sold
All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm.
Stryker Spine is recalling Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by Stryker Spine SAS, due to Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026