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Exactech Acumatch a-Series & Mcs Constrained Acetabular Liners

by Exactech, Inc.

510(k) K040601

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 · Abbreviated NumberK040601 Date4 Oct 2004ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1725-2022 FDA Class II initiated 11 Aug 2022

    Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

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  • Withdrawn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
KWZ
Device Class
Class II
Regulation
21 CFR Part 888.3310
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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