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Gpac II Knee System RD146722

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 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 Number00880304135048 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0628-2018 FDA Class II initiated 25 Aug 2017
    • Terminated Z-0627-2018 FDA Class II initiated 25 Aug 2017

    The affected AGC 2000 LP Patella products were over-molded leaving the outside diameter nonconforming to the print dimension.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gpac II Knee System
Generic Name
Uncoated knee femur prosthesis, metallic
Model / Ref / Catalog
RD146722
Primary DI / UDI-DI
00880304135048
510(k) Number
FDA Product Code
JWH
GMDN Term
Uncoated knee femur prosthesis, metallic
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Uncoated knee femur prosthesis, metallic

Cleared under the same submission (K833921)

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