Class II — Potential Health Hazard

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

Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm Recalled by Integra LifeSciences Corporation Due to New Deal has identified through a complaint report...

Date: March 28, 2014
Company: Integra LifeSciences Corporation
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 Integra LifeSciences Corporation directly.

Affected Products

Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.

Quantity: 417 units

Why Was This Recalled?

New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).

Where Was This Sold?

This product was distributed to 4 states: AR, CA, NC, TX

Affected (4 states)Not affected

About Integra LifeSciences Corporation

Integra LifeSciences Corporation has 29 total recalls tracked by RecallDetector.

Related Recalls

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