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Affixus® 815408280

by Zimmer, Inc.

Affixus® 815408280 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K241651 on 26 Sep 2024 and listed in FDA GUDID since 16 Oct 2024 (UDI-DI 00887868583582), active as of 23 Oct 2026. 17 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

17 ongoing

This device is named in the recall

Documents

510(k) K241651

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868583582 UDI-DI Date16 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241651 Date26 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241651 decided 26 Sep 2024 Active
  • FDA GUDID UDI-DI 00887868583582 listed 16 Oct 2024 Listed

Recalls

17 recalls · 17 ongoing · FDA

  • 17 recalls, same reason

    • Ongoing Z-0972-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0975-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0981-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0982-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0971-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0980-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0970-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0977-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0974-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0976-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0978-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0983-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0968-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0967-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0969-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0973-2026 FDA Class II initiated 2 Dec 2025
    • Ongoing Z-0979-2026 FDA Class II initiated 2 Dec 2025

    Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-0977-2026
  2. Recall initiated FDA recalls Z-0974-2026
  3. Recall initiated FDA recalls Z-0976-2026
  4. Recall initiated FDA recalls Z-0978-2026
  5. Recall initiated FDA recalls Z-0983-2026
  6. Recall initiated FDA recalls Z-0968-2026
  7. Recall initiated FDA recalls Z-0967-2026
  8. Recall initiated FDA recalls Z-0969-2026
  9. Recall initiated FDA recalls Z-0973-2026
  10. Recall initiated FDA recalls Z-0979-2026

9 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Affixus®
Generic name
Tibia intramedullary nail
Model / Ref / Catalog
815408280
Primary DI / UDI-DI
00887868583582
510(k) Number
FDA product code
HWC, HSB
GMDN term
Tibia intramedullary nail
Device class
Class II
Regulation number
888.3040, 888.3020
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Tibia intramedullary nail

Cleared under the same submission (K241651)

and 8 more cleared under K241651

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)