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Recall Observatory FDA recall evidence

Device product

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

Z-0097-2018

October 24, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 78390
Status
Ongoing
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-0097-2018

Official wording

Reason: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

Code information: Lot number 16LM07111

Distribution pattern: US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.