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Na 71070806

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

27 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 Number03596010495549 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

27 recalls · FDA

  • 27 recalls, same reason

    • Terminated Z-1727-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1769-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1728-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1736-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1768-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1730-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1738-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1742-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1739-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1741-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1725-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1745-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1737-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1733-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1726-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1732-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1740-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1743-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1767-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1731-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1770-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1734-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1744-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1772-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1729-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1746-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1771-2012 FDA Not yet classified initiated 13 Apr 2012

    Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic bone pin, non-bioabsorbable
Model / Ref / Catalog
71070806
Description
HYDROXYAPATITE HALF PIN 6MM DIAMETER 35MM THREAD X 150MM SHANK
Primary DI / UDI-DI
03596010495549
510(k) Number
FDA Product Code
JDW
GMDN Term
Orthopaedic bone pin, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K023921)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • 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