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Biomet Femoral Locking Nail System

by Biomet Manufacturing Corp

510(k) K072161

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK072161 Date20 Sep 2007ClearedStatusActive

Recalls

8 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-2282-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2283-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2279-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2277-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2280-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2278-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009
    • Terminated Z-2281-2009 FDA Unclassified (pre-2012) initiated 2 Apr 2009

    Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.

    • Terminated Z-2115-2009 FDA Unclassified (pre-2012) initiated 27 Mar 2009

    Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.

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  • Withdrawn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
HSB
Device Class
Class II
Regulation
21 CFR Part 888.3020
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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