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Recall Observatory FDA recall evidence

Device product

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Z-2163-2018

May 04, 2018

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 80125
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-2163-2018

Official wording

Reason: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

Code information: 15FM16181

Distribution pattern: International only: United Arab Emirates, Spain, Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.