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StageOne Select 431191

by Biomet Orthopedics, Inc. United States GUDID

Product code KWL

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868551628 UDI-DIDate17 Mar 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-1641-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1649-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1640-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1648-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1651-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1638-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1650-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1643-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1646-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1642-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1645-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1644-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1652-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1639-2020 FDA Class II initiated 26 Feb 2020
    • Terminated Z-1647-2020 FDA Class II initiated 26 Feb 2020

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

Specification

GUDID · synced 23 Oct 2026

Trade Name
StageOne Select
Generic Name
Orthopaedic cement spacer mould
Model / Ref / Catalog
431191
Primary DI / UDI-DI
00887868551628
510(k) Number
FDA Product Code
KWL, KWY, MBB
GMDN Term
Orthopaedic cement spacer mould
Device Class
Class II
Regulation Number
888.3360, 888.3390, 888.3027
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • 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

Sources (1)

  • FDA UDI f9d2e08d-d30f-4e6e-be47-7651259ab2ee 35 fields · synced 23 Oct 2026