Natural-Knee II System-Durasul Tibial Insert and Durasul All-Poly Patella

• 8 recalls, same reason

  • Terminated Z-0851-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0854-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0848-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0849-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0853-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0855-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0850-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0852-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011

  The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene, Durasul, patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used

510(k) Number

K002335 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Natural-Hip Cocr Offset Stem

  Class II

  FDA 510(k) K973681 Active Cleared 19 Dec 1997

• Sulzer Orthopedics Converge Acetabular System

  Class II

  FDA 510(k) K012961 Active Cleared 18 Oct 2001

• Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts

  Class II

  FDA 510(k) K983153 Active Cleared 4 Dec 1998

• Natural-Hip Porous Stem with Offset

  Class II

  FDA 510(k) K973675 Active Cleared 19 Dec 1997

• Allofit Acetabular System 32mm Alpha Durasul Inserts

  Class II

  FDA 510(k) K013935 Active Cleared 13 Dec 2001

• Magna-Rom 21 Knee Systeem

  Class II

  FDA 510(k) K991143 Active Cleared 11 Jun 1999

See all devices from Sulzer Orthopedics, Inc. →