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Reclaim 1975-00-085

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 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 Number10603295076841 UDI-DI Date24 Mar 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2082-2014 FDA Class II initiated 3 Jun 2014 on shared 510(k) K102080
    • Terminated Z-2084-2014 FDA Class II initiated 3 Jun 2014 on shared 510(k) K102080
    • Terminated Z-2083-2014 FDA Class II initiated 3 Jun 2014 on shared 510(k) K102080

    The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

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  • Withdrawn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
Reclaim
Generic Name
Uncoated hip femur prosthesis, modular
Model / Ref / Catalog
1975-00-085, 197500085
Primary DI / UDI-DI
10603295076841
510(k) Number
FDA Product Code
LZO
GMDN Term
Uncoated hip femur prosthesis, modular
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated hip femur prosthesis, modular

Cleared under the same submission (K102080)

Show all (12)

Other devices from Depuy (Ireland)

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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