Integra LifeSciences Corporation: Medical Device Recall in 2014 - (Recall #: Z-1697-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 28, 2014

Date Posted: June 11, 2014

Recall Number: Z-1697-2014

Event ID: 68284

Reason for Recall:

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).

Status: Terminated

Product Quantity: 417 units

Code Information:

SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6; SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL

Distribution Pattern:

Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated