Integra LifeSciences Corporation Recall: Integra Newdeal SURFIX Fixed Angle Locking Screw
Integra LifeSciences Corporation Recall: Integra Newdeal SURFIX Fixed Angle Locking Screw is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Integra LifeSciences Corporation; Product: Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Product | 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20140328 |
| Recall number | Z-1697-2014 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →