Omnifit Self Tapping Cancellous Bone Screws

• • Terminated Z-0483-2014 FDA Class II ·initiated 1 Oct 2013

  Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

• 2 recalls, same reason

  • Terminated Z-0388-2013 FDA Class II ·initiated 17 Aug 2012
  • Terminated Z-0387-2013 FDA Class II ·initiated 17 Aug 2012

  Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

• • Terminated Z-2007-2008 FDA Unclassified (pre-2012) ·initiated 20 Dec 2005

  The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

510(k) Number

K894124 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

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  FDA 510(k) K870235 Active Cleared 29 May 1987

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• Osteonics(R) Mpss Hip Stem Series

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  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →