Recalls / —
—#115887
Product
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.
- FDA product code
- JDS — Nail, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K981529
- Affected lot / code info
- Batch Number 12JM17051
Why it was recalled
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 (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2013-02-07
- Posted by FDA
- 2013-03-13
- Terminated
- 2016-01-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #115887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.