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Contour 71367641

by Smith & Nephew, Inc.

Contour 71367641 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K123598 on 28 Jun 2013 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010607294), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K123598

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03596010607294 UDI-DI Date30 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123598 Date28 Jun 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123598 decided 28 Jun 2013 Active
  • FDA GUDID UDI-DI 03596010607294 listed 30 Aug 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0730-2019 FDA Class II initiated 7 Jan 2019 on shared 510(k) K123598

    The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

    • Terminated Z-1008-2017 FDA Class II initiated 16 Nov 2016 on shared 510(k) K123598

    The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K123598
  2. Listed FDA GUDID 03596010607294
  3. Recall initiated FDA recalls Z-1008-2017
  4. Recall initiated FDA recalls Z-0730-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Contour
Generic name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
71367641
Primary DI / UDI-DI
03596010607294
510(k) Number
FDA product code
JDG
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class II
Regulation number
888.3360
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K123598)

and 8 more cleared under K123598

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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