| | Class 2 Recall
INTERNAL HEX RECON SCREW |  |
| Date Posted |
March 13, 2013 |
| Recall Number |
Z-0943-2013 |
| Product |
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. |
| Code Information |
Batch Number 12KM01206
|
Recalling Firm/
Manufacturer |
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Joe Metzger
978-749-1330
|
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 |
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 in Commerce |
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. |
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