Acromed Pedicle Screw

• • Terminated Z-1011-2014 FDA Class II ·initiated 11 Oct 2013 ·on shared 510(k) K965102

  Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

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

510(k) Number

K965102 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• University Plate Anterior System

  Class II

  FDA 510(k) K980228 Active Cleared 14 Apr 1998

• Acromed Double Sublaminar Wire

  Class II

  FDA 510(k) K895413 Active Cleared 22 Nov 1989

• Isola(R) Tandem Connector

  Class II

  FDA 510(k) K922504 Active Cleared 18 May 1993

• Acromed Pedicle Screw

  Class II

  FDA 510(k) K951116 Active Cleared 11 Aug 1995

• Vsp (Variable Screw Placement) Spinal Fixation System, Pedicle Screw(S), Spine Plate(S), Washer(S) & Nut(S)

  Class II

  FDA 510(k) K951657 Active Cleared 21 Aug 1995

• Isola(Tm) Spine System--Eye Rod

  Class II

  FDA 510(k) K911394 Active Cleared 21 Jun 1991

See all devices from Acromed Corp. →