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Endo-Model Standard Knee Prosthesis System SL 15-8571/13

by WALDEMAR LINK GmbH & Co. KG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

16 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04026575224333 UDI-DI Date13 Aug 2021ListedStatusListed GUDID: in commercial distribution

Recalls

16 recalls · 16 ongoing · FDA

  • 13 recalls, same reason

    • Ongoing Z-1512-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1513-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1518-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1516-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1522-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1521-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1520-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1519-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1517-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1515-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1523-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1511-2026 FDA Class II initiated 12 Jan 2026
    • Ongoing Z-1514-2026 FDA Class II initiated 12 Jan 2026

    The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

    • Ongoing Z-0890-2026 FDA Class II initiated 10 Nov 2025

    The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

  • 2 recalls, same reason

    • Ongoing Z-2410-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008
    • Ongoing Z-2411-2024 FDA Class II initiated 22 May 2024 on shared 510(k) K151008

    Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Endo-Model Standard Knee Prosthesis System SL
Generic Name
Knee arthroplasty wedge
Model / Ref / Catalog
15-8571/13
Primary DI / UDI-DI
04026575224333
510(k) Number
FDA Product Code
KRO
GMDN Term
Knee arthroplasty wedge
Device Class
Class II
Regulation Number
888.3510
GUDID distribution status
In Commercial Distribution

Related devices

Category: Knee arthroplasty wedge

Cleared under the same submission (K151008)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No