Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). Manufactured by Stryker Spine SAS, Cestas, F
FDA device recall Z-0217-2009 · posted 2008-11-20 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.
- Action taken
- An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 183 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-08-18
- Date posted
- 2008-11-20
- Date terminated
- 2009-06-19
- Location
- Allendale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K040261) | Stryker Spine | 2004-04-16 |