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01-007-04-3220

by Exactech, Inc.

01-007-04-3220 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K182346 on 26 Nov 2018 (3 earlier submissions) and listed in FDA GUDID since 18 Aug 2022 (UDI-DI 10885862552938), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10885862552938 UDI-DI Date18 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182346 Date26 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182346 decided 26 Nov 2018 Active· +3 more in the status table
  • FDA GUDID UDI-DI 10885862552938 listed 18 Aug 2022 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1734-2022 FDA Class II initiated 11 Aug 2022

    Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

    • Terminated Z-1031-2017 FDA Class II initiated 7 Nov 2016

    Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Timeline

7 dated events

  1. Cleared FDA 510(k) K896601
  2. Cleared FDA 510(k) K993082
  3. Cleared FDA 510(k) K141797
  4. Recall initiated FDA recalls Z-1031-2017
  5. Cleared FDA 510(k) K182346
  6. Recall initiated FDA recalls Z-1734-2022
  7. Listed FDA GUDID 10885862552938

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
01-007-04-3220
Primary DI / UDI-DI
10885862552938
510(k) Number
FDA product code
HWC, LPH, JWH, MBH, JDI
GMDN term
Fluted surgical drill bit, reusable
Device class
Class II
Regulation number
888.3040, 888.3358, 888.3560, 888.3565, 888.3350
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 3.2 Millimeter
Length — 20 Millimeter

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K141797)

and 8 more cleared under K141797

Cleared under the same submission (K182346)

and 8 more cleared under K182346

Similar devices in this category

Other devices filed under Fluted surgical drill bit, reusable.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)