Integra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
Integra LifeSciences is recalling specific lots of SURFIX locking screws because some 22mm units were mislabeled as 30mm units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corporation is recalling 417 units of Newdeal SURFIX Fixed Angle Locking Screws. The recall involves 3.5mm x 22mm screws (Catalog No. 285322S, Lot No. F6S6) and 3.5mm x 30mm screws (Catalog No. 285330S, Lot No. F6ZL). These medical devices are used to anchor bone fixation plates during the treatment of bone fractures or reconstruction of the ankle, foot, or hand.
The recall was initiated after a complaint report identified that some 3.5mm x 22mm screws in Lot No. F626 were packaged and labeled as 3.5mm x 30mm screws. This labeling discrepancy could lead to the use of the incorrect screw length during surgical procedures.
The affected products were distributed worldwide, including in the United States (specifically AR, CA, NC, and TX) and internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, the United Arab Emirates, and the United Kingdom. Healthcare providers should stop using the affected lots and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 417
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 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
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