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Durom Hip Resurfacing System, Femoral Components

by Zimmer GmbH

510(k) K070292

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070292 Date26 Apr 2007ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0216-2013 FDA Class II initiated 4 Sep 2012

    Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

  • 2 recalls, same reason

    • Terminated Z-0276-2008 FDA Unclassified (pre-2012) initiated 26 Sep 2007
    • Terminated Z-0275-2008 FDA Unclassified (pre-2012) initiated 26 Sep 2007

    Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KXA
Device Class
Class II
Regulation
21 CFR Part 888.3400
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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