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Na 03.111.032

by Synthes

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

7 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 Number10886982072306 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0880-2020 FDA Class II initiated 16 Dec 2019
    • Terminated Z-0881-2020 FDA Class II initiated 16 Dec 2019
    • Terminated Z-0882-2020 FDA Class II initiated 16 Dec 2019
    • Terminated Z-0879-2020 FDA Class II initiated 16 Dec 2019
    • Terminated Z-0883-2020 FDA Class II initiated 16 Dec 2019

    There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

    • Terminated Z-2389-2016 FDA Class II initiated 28 Jun 2016

    It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.

    • Terminated Z-0323-2016 FDA Class II initiated 2 Nov 2015

    It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
03.111.032, 03111032
Primary DI / UDI-DI
10886982072306
510(k) Number
FDA Product Code
HRS, HWC
GMDN Term
Bone-resection orthopaedic reamer, reusable
Device Class
Class II
Regulation Number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-resection orthopaedic reamer, reusable

Cleared under the same submission (K103243)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

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