Recall Z-0944-2013 ยท JDS Nail, Fixation, Bone
Smith & Nephew Inc
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
| Date | Mar 13, 2013 (initiated Feb 7, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 90 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981529 | TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW Smith & Nephew, Inc., Jul 9, 1998 |