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Monoblock Hex Screwdriver 110003330

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00880304566651 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0007-2023 FDA Class II initiated 25 Aug 2022

    The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

  • 2 recalls, same reason

    • Terminated Z-1837-2014 FDA Class II initiated 7 May 2014
    • Terminated Z-1838-2014 FDA Class II initiated 7 May 2014

    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Monoblock Hex Screwdriver
Generic Name
Surgical screwdriver, reusable
Model / Ref / Catalog
110003330
Primary DI / UDI-DI
00880304566651
510(k) Number
FDA Product Code
LWZ, OQG, LPH, PBI, OQI, LZO, JDI, OQH, KWZ
GMDN Term
Surgical screwdriver, reusable
Device Class
Class III
Regulation Number
888.3358, 888.3310, 888.3353, 888.3350
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Cleared under the same submission (K121874)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No