Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended Recalled by Synthes (USA) Products LLC Due to It was discovered that the above part number...

Date: November 2, 2015
Company: Synthes (USA) Products LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Synthes (USA) Products LLC directly.

Affected Products

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Quantity: 229

Why Was This Recalled?

It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).

Where Was This Sold?

This product was distributed to 27 states: AL, CA, CO, CT, FL, GA, ID, IN, IA, KS, MD, MA, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, VA, WA, WV

Affected (27 states)Not affected

About Synthes (USA) Products LLC

Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report