FDA Medical Device Recalls (openFDA)
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 number
- Z-1959-2009
- Recalling firm
- Stryker Spine
- 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.
- Status
- Terminated
- Initiated
- 2006-06-14
- Posted
- 2009-08-20
- Terminated
- 2009-08-20
- Reason
- 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
- 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
- 109572 total screws, self tapping and self drilling.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K040261"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28