S-Rom/Noiles Mark 3

• 3 recalls, same reason

  • Terminated Z-1207-2014 FDA Class II ·initiated 24 Feb 2014 ·on shared 510(k) K896048
  • Terminated Z-1208-2014 FDA Class II ·initiated 24 Feb 2014 ·on shared 510(k) K896048
  • Terminated Z-1206-2014 FDA Class II ·initiated 24 Feb 2014

  DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa

• 2 recalls, same reason

  • Terminated Z-1204-2014 FDA Class II ·initiated 24 Feb 2014
  • Terminated Z-1205-2014 FDA Class II ·initiated 24 Feb 2014

  DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p

• • Terminated Z-1203-2014 FDA Class II ·initiated 24 Feb 2014

  DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the

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

510(k) Number

K896048 ↗

FDA Product Code

KRO

Device Class

Class II

Regulation

21 CFR Part 888.3510

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• S-ROM Total Hip Replacement System

  Class II

  FDA 510(k) K920739 Active Cleared 24 Nov 1992

• S-ROM ZTT Acetabular Cup-Apical Hole Plug

  Class III

  FDA 510(k) K931676 Active Cleared 18 May 1994

• S-Rom Femoral Hip Stem - Size 14 X 8

  Class II

  FDA 510(k) K954935 Active Cleared 22 Jan 1996

• Knee Prothesis

  Class II

  FDA 510(k) K941769 Active Cleared 1 Feb 1995

• Src Total Knee

  Not classified

  FDA 510(k) K841022 Active Cleared 25 Jun 1984

• S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis

  Class II

  FDA 510(k) K951084 Active Cleared 31 May 1995

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