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Actis 1010-14-120

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number10603295421054 UDI-DI Date13 Nov 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0650-2017 FDA Class II initiated 25 Oct 2016

    DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Actis
Generic Name
Coated femoral stem prosthesis, one-piece
Model / Ref / Catalog
1010-14-120, 101014120
Primary DI / UDI-DI
10603295421054
510(k) Number
FDA Product Code
LPH, KWL, MEH, KWY
GMDN Term
Coated femoral stem prosthesis, one-piece
Device Class
Class II
Regulation Number
888.3358, 888.3360, 888.3353, 888.3390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated femoral stem prosthesis, one-piece

Cleared under the same submission (K150862)

Show all (12)

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

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