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Cannulated Screw 110009956

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

5 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 Number00887868519277 UDI-DI Date23 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0617-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0618-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

  • 2 recalls, same reason

    • Terminated Z-2304-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2303-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

    • Terminated Z-1064-2018 FDA Class II initiated 7 Dec 2017

    One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Cannulated Screw
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
110009956
Primary DI / UDI-DI
00887868519277
510(k) Number
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K140891)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • 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