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Arcomxl Polyethylene Liners and 38/40mm Femoral Heads

by Biomet Manufacturing Corp

510(k) K062997

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK062997 Date8 Dec 2006ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1143-2012 FDA Not yet classified initiated 7 Feb 2012

    Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.

    • Terminated Z-1449-2012 FDA Unclassified (pre-2012) initiated 13 Sep 2011

    Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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