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Recall Observatory FDA recall evidence

Device 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.

Z-0944-2013

February 07, 2013

Class II

Product summary

Firm
Smith & Nephew Inc
Event
Event 64342
Status
Terminated
Classification
Class II
Quantity
90 units
Official record key
device-enforcement:Z-0944-2013

Official wording

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.

Code information: Batch Number 12JM17051

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.