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Na 03.000.084S

by Synthes United States GUDID

Product code HWE

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10887587008509 UDI-DIDate30 Jun 2016ListedStatusIn 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

6 recalls · FDA

    • Terminated Z-0681-2017 FDA Class II initiated 1 Nov 2016

    Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

  • 2 recalls, same reason

    • Terminated Z-2784-2016 FDA Class I initiated 24 Jun 2016
    • Terminated Z-2783-2016 FDA Class I initiated 24 Jun 2016

    There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

    • Terminated Z-2199-2016 FDA Class II initiated 31 May 2016

    DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

    • Terminated Z-1313-2015 FDA Class II initiated 19 Dec 2014

    In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

    • Terminated Z-0615-2014 FDA Class II initiated 15 Apr 2013

    Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Orthopaedic bur, reusable
Model / Ref / Catalog
03.000.084S, 03000084S
Primary DI / UDI-DI
10887587008509
510(k) Number
FDA Product Code
HWE, ERL, HBE, DZI
GMDN Term
Orthopaedic bur, reusable
Device Class
Class I
Regulation Number
878.4820, 874.4250, 882.4310, 872.4120
Commercial Distribution
In Commercial Distribution

Related devices

Category: Orthopaedic bur, reusable

Cleared under the same submission (K043310)

Show all (12)

Other devices from Synthes

See all devices from Synthes →

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 e4b0d3ce-0390-44bb-b252-8d81ade678b8 36 fields · synced 23 Oct 2026