Z-1697-2014 Class II Terminated
FDA device recall Z-1697-2014 was initiated by Integra LifeSciences Corporation on March 28, 2014 and is designated Class II. 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 … The recall status is terminated (terminated April 18, 2016). Affected quantity: 417 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2014
- Initiation Date
- March 28, 2014
- Termination Date
- April 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 417 units
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.
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).
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.
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