smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is int
FDA device recall Z-0411-2011 · posted 2010-11-18 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.
- Action taken
- Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.
- Root cause
- Other
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 445 units
- Distribution
- Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China
- Date initiated
- 2010-10-15
- Date posted
- 2010-11-18
- Date terminated
- 2011-02-17
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 (K100107) | Smith & Nephew, Inc. | 2010-02-23 |