Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Dist
FDA device recall Z-1960-2009 · posted 2009-08-20 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 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.
- Date initiated
- 2006-06-14
- Date posted
- 2009-08-20
- Date terminated
- 2009-08-20
- Location
- Allendale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K040261) | Stryker Spine | 2004-04-16 |