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Panalok Loop Anchor

by Depuy Mitek, A Johnson & Johnson Company

510(k) K040827

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

5 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 · Special NumberK040827 Date30 Apr 2004ClearedStatusActive

Recalls

17 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1678-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1681-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1679-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1677-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1680-2023 FDA Class II initiated 13 Apr 2023

    IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

  • 10 recalls, same reason

    • Terminated Z-1168-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1166-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1163-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1171-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1162-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1169-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1164-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1170-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1165-2012 FDA Not yet classified initiated 27 Jan 2012
    • Terminated Z-1167-2012 FDA Not yet classified initiated 27 Jan 2012

    Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair

  • 2 recalls, same reason

    • Terminated Z-0318-2012 FDA Unclassified (pre-2012) initiated 31 Oct 2011
    • Terminated Z-0314-2012 FDA Unclassified (pre-2012) initiated 31 Oct 2011

    Incorrect suture configuration

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
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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