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Recall Observatory FDA recall evidence

Device product

smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.

Z-1921-2018

May 02, 2018

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 80050
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-1921-2018

Official wording

Reason: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

Code information: Lot Numbers: 17LM22019, 17LM10934, 17LM05900

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.