Wire & Steinman Pins

• 13 recalls, same reason

  • Terminated Z-2231-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2241-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2240-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2242-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2235-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2234-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2233-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2236-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2239-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2237-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2238-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2230-2018 FDA Class II ·initiated 16 May 2018
  • Terminated Z-2232-2018 FDA Class II ·initiated 16 May 2018

  The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

• • Terminated Z-0087-2017 FDA Class II ·initiated 2 Aug 2016

  The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.

• • Terminated Z-1822-2016 FDA Class II ·initiated 1 Apr 2016

  Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

510(k) Number

K831005 ↗

FDA Product Code

HTY

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

• Segmental Spinal Instrumentation System

  Not classified

  FDA 510(k) K864337 Active Cleared 16 Dec 1986

See all devices from Kirschner Medical Corp. →

• What types of orthopedic procedures are these pins designed for, and how do their tip configurations help in those procedures?

  The Wire & Steinmann Pins are designed for internal skeletal stabilization in orthopedic surgeries, such as fracture fixation or bone alignment. The pins come in single-ended and double-ended versions, along with varying lengths and diameters, to suit different clinical needs. The tip configurations (not explicitly detailed but implied by the design) likely include options like sharp, blunt, or threaded tips, which help with precise insertion, reduced trauma to bone tissue, or improved grip for stability during healing.

• Are these pins reusable, or are they intended for single-use only? How should they be handled to maintain sterility?

  These pins are intended for single-use only, as explicitly stated in the device description. To maintain sterility, they are supplied in sterile packaging, so they must be handled using standard surgical protocols—such as keeping the sterile barrier intact until use, avoiding contamination, and adhering to facility-specific sterilization guidelines for orthopedic implants.

• What materials are these pins made from, and why does that matter for surgical applications?

  The pins are manufactured from DIN 1.4441 (316LVM) stainless steel, a grade known for its biocompatibility and corrosion resistance, ensuring they are safe for internal use in the body. Compliance with ISO 5832-1 and ASTM F138 standards further confirms their suitability for surgical applications, as these certifications validate the material’s reliability and performance in orthopedic fixation.

• How do I determine the correct size or model for a specific patient or procedure?

  The pins come in various lengths, diameters, and tip configurations to accommodate different clinical needs. The correct size depends on factors like the patient’s anatomy, the type of fracture or bone involved, and the surgeon’s preference for stability. Consulting the manufacturer’s surgical technique guides (if available) or working with the supplier can help match the right pin specifications to the procedure, ensuring proper fixation and minimizing complications.

• What regulatory pathway was followed for FDA clearance, and how does that affect their use in clinical settings?

  These pins received FDA 510(k) clearance through a Traditional review process, with the Orthopedic (OR) Advisory Committee providing input. This means the device was deemed substantially equivalent to a legally marketed predicate, ensuring it meets FDA safety and effectiveness standards. Clinically, this clearance indicates the pins have undergone rigorous evaluation, but as always, surgeons should follow institutional protocols and manufacturer instructions for proper use.