Omnifit Bone Screw

• 28 recalls, same reason

  • Terminated Z-2122-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2130-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2125-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2119-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2120-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2136-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2124-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2141-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2138-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2134-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2176-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2128-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2127-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2133-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2132-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2126-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2142-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2117-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2140-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2118-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2121-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2143-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2139-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2137-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2135-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009 ·on shared 510(k) K873251
  • Terminated Z-2129-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2123-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009
  • Terminated Z-2131-2009 FDA Unclassified (pre-2012) ·initiated 26 Jun 2009

  Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

• • 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K873251 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SN

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →