Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a s
FDA device recall Z-0455-2014 · posted 2013-12-05 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- A potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.
- Action taken
- Synthes sent an email message dated March 23, 2012, to the sales representative who received the affected product. The email identified the product, the problem, and the action to be taken. The letter requested the sales rep examine inventory, stop using the product, and quarantine the affected product to ensure that it will not be used. Synthes instructed the customer not to remove any product from their account or return any product without further instruction. For questions they were instructed to call 610-719-5364. For questions regarding this recall call 610-719-5000.
- Root cause
- Process design
- Status
- Terminated
- Product code
- OVE
- Quantity affected
- 1
- Distribution
- Nationwide Distribution - only AZ .
- Date initiated
- 2013-09-30
- Date posted
- 2013-12-05
- Date terminated
- 2015-04-16
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES ZERO-P VARIABLE ANGLE (VA) (K112068) | Synthes Spine Co.Lp | 2011-11-07 |