3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation Syste
FDA device recall Z-2452-2015 · posted 2015-08-24 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- Reason for recall
- The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
- Action taken
- Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 121 units
- Distribution
- Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
- Date initiated
- 2015-07-20
- Date posted
- 2015-08-24
- Date terminated
- 2017-01-26
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIGER CANNULATED SCREW SYSTEM (K081510) | Trilliant Surgical, Ltd. | 2008-08-04 |