Distal Centralizer, Exeter II Hip System

• 2 recalls, same reason

  • Terminated Z-1594-2010 FDA Unclassified (pre-2012) ·initiated 31 Mar 2010
  • Terminated Z-1593-2010 FDA Unclassified (pre-2012) ·initiated 31 Mar 2010

  One lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.

• • Terminated Z-1601-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010

  Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.

510(k) Number

K974054 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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