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Na 71932591

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K211176; other models may be affected

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 Number00885556057230 UDI-DI Date29 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024 on shared 510(k) K211176

    The Bipolar assembly contains an oversized Retainer Ring.

    • Terminated Z-1921-2018 FDA Class II initiated 2 May 2018

    Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

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  • Withdrawn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

Generic Name
Press-fit femoral stem prosthesis
Model / Ref / Catalog
71932591
Primary DI / UDI-DI
00885556057230
510(k) Number
FDA Product Code
JDI
GMDN Term
Press-fit femoral stem prosthesis
Device Class
Class II
Regulation Number
888.3350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Press-fit femoral stem prosthesis

Cleared under the same submission (K052792)

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Cleared under the same submission (K211176)

Show all (12)

Cleared under the same submission (K240783)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

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