D-Rad Smart Pack

• • Terminated Z-1317-2018 FDA Class II ·initiated 7 Mar 2018 ·on shared 510(k) K132296

  One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

• 3 recalls, same reason

  • Terminated Z-1855-2017 FDA Class II ·initiated 9 Mar 2017 ·on shared 510(k) K132296
  • Terminated Z-1857-2017 FDA Class II ·initiated 9 Mar 2017 ·on shared 510(k) K132296
  • Terminated Z-1856-2017 FDA Class II ·initiated 9 Mar 2017 ·on shared 510(k) K132296

  The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

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

1. 7 Jan 2014 Cleared FDA 510(k) K132296
2. 9 Mar 2017 Recall initiated FDA recalls Z-1855-2017
3. 9 Mar 2017 Recall initiated FDA recalls Z-1857-2017
4. 9 Mar 2017 Recall initiated FDA recalls Z-1856-2017
5. 7 Mar 2018 Recall initiated FDA recalls Z-1317-2018

510(k) Number

K132296 ↗

FDA product code

HRS

Device class

Class II

Regulation

21 CFR Part 888.3030

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

• ACUMED 71-0459 by ACUMED LLC
• ACUMED 7007-0303L by ACUMED LLC
• Arthrex® AR-8835CL-28 by Arthrex, Inc.
• Arthrex® AR-8933L-36S by Arthrex, Inc.
• OsteoMed 320-1002 by Osteomed Corp.
• PCF-318S by TDM Co., Ltd.
• MLP Special Locking Bone Plate System by Maxxion Medical, LLC / Baumer SA
• OsteoMed 336-7103 by Osteomed Corp.
• RIBFIX BLU SYSTEM 76-2707 by BIOMET MICROFIXATION, INC
• Valkyrie Thoracic Fixation System by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

• Real Intelligence ROB30801

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• Real Intelligence ROB30007

  Class II

  FDA 510(k) K252841 Active Cleared 5 Dec 2025 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-01

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

• PyroCarbon Modular Radial Head TRL-310-04

  Class II

  FDA 510(k) K032686 Active Cleared 22 Oct 2003 GUDID on market

See all devices from Smith & Nephew, Inc. →