INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM,
FDA device recall Z-0943-2013 · posted 2013-03-13 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
- Action taken
- Smith & Nephew sales representatives and Smith & Nephew international distributors were notified of problem and the recall via email on February 7, 2013. They were instructed to cease use and distribution of the product and quarantine for return. Non responding consignees were notified again on February 28, 2013 by email. Hospitals were notified by letter beginning on February 7, 2013. Smith & Nephew also contacted the surgeons who implanted the screws by letter the week of February 11th. For questions regarding this recall call 978-749-1330.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 69 units
- Distribution
- Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.
- Date initiated
- 2013-02-07
- Date posted
- 2013-03-13
- Date terminated
- 2016-01-11
- 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 |
|---|---|---|
| TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW (K981529) | Smith & Nephew, Inc. | 1998-07-09 |