Dupuy Cement Restrictor Trials & Instr.

• 5 recalls, same reason

  • Terminated Z-1687-2011 FDA Unclassified (pre-2012) ·initiated 27 Jan 2011 ·on shared 510(k) K800894
  • Terminated Z-1686-2011 FDA Unclassified (pre-2012) ·initiated 27 Jan 2011 ·on shared 510(k) K800894
  • Terminated Z-1689-2011 FDA Unclassified (pre-2012) ·initiated 27 Jan 2011 ·on shared 510(k) K800894
  • Terminated Z-1688-2011 FDA Unclassified (pre-2012) ·initiated 27 Jan 2011 ·on shared 510(k) K800894
  • Terminated Z-1690-2011 FDA Unclassified (pre-2012) ·initiated 27 Jan 2011 ·on shared 510(k) K800894

  The firm became aware of a manufacturing error resulting in a potentially incomplete seal of the outer pouch. Although the sterility of the product is not compromised, the sterility of the inner pouch containing the product cannot be assured. Lack of sterility of the inner pouch could potentially cause contamination of the sterile field, including the implant. Non-sterile product and/or contaminat

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

510(k) Number

K800894 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →