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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Integra LifeSciences Corporation
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
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:
Distributed in: AR, CA, NC, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1697-2014
Related Recalls
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Integra LifeSciences
Possibility for the obturator to break (separate).
Potential that the induction seal is not completely sealed to the device tube packaging.
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.