L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar
FDA device recall Z-1461-2017 · posted 2017-02-27 · Terminated
Recall details
- Recalling firm
- Kiscomedica S.A.
- Reason for recall
- Firm received a complaint of the tip holder breaking during use.
- Action taken
- Manufacturer's Field Safety Corrective Action Report was submitted to ANSM (French Health Products Safety Agency) on January 11, 2017. The Field Safety Notice was sent to U.S. Consignee on January 18, 2017. The letter identified the affected product, problem and actions to be taken.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 13 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of MO and country of Switzerland.
- Date initiated
- 2017-01-11
- Date posted
- 2017-02-27
- Location
- Saint Priest, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| L-VARLOCK (K080537) | Kiscomedica S.A. | 2008-06-30 |