Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
FDA device recall Z-0932-2013 · posted 2013-03-10 · Terminated
Recall details
- Recalling firm
- Spine Smith Partners LP
- Reason for recall
- Implants were incorrectly laser marked as 23mm instead of 28mm.
- Action taken
- Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 3 units
- Distribution
- Distributed in Texas.
- Date initiated
- 2012-08-24
- Date posted
- 2013-03-10
- Date terminated
- 2013-05-17
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINESMITH CYNCH SPINAL SYSTEM (K101085) | Spine Smith Partners L.P. | 2010-07-01 |