DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide
FDA device recall Z-1670-2009 · posted 2009-08-14 · Terminated
Recall details
- Recalling firm
- DePuy Spine, Inc.
- Reason for recall
- Tip of Driver may break during use
- Action taken
- DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 117 units
- Distribution
- Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
- Date initiated
- 2009-02-11
- Date posted
- 2009-08-14
- Date terminated
- 2015-07-09
- Location
- Raynham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXPEDIUM SFX CROSS CONNECTOR SYSTEM (K070300) | Depuy Spine, Inc. | 2007-04-10 |