Recall Z-1960-2009
Stryker Spine · initiated June 14, 2006
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.
Codes / 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.
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1960-2009
- Initiated
- June 14, 2006
- Posted by FDA
- August 20, 2009
- Terminated
- August 20, 2009
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Quantity
- 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.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1958-2009 | Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile; Manufactured by…Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All… | 06/14/2006Terminated |
| Z-1959-2009 | Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. Manufactured by Stryker…Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All… | 06/14/2006Terminated |