Integra LifeSciences Recalls QWIX Compression Screws Due to Labeling Error
Integra LifeSciences is recalling QWIX Compression Screws because the product labeling incorrectly identifies them as compression screws rather than positioning screws.
What this means for you
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 involves a labeling error where the product type is misidentified. This fits the rubric criterion for minor labeling errors or low-risk contamination, as no injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling Large QWIX Compression screws, diameter 7.5 mm, length 90 mm, Lot No. FH86. The recall involves 120 units from multiple lots distributed nationwide in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA, and WA.
The recall was initiated because the product labeling states that the item is a "compression screw" instead of a "positioning screw." The QWIX Positioning screw is indicated for the fixation of bone fractures or for bone reconstruction. The affected model numbers include 121530S through 121820S.
Healthcare providers and patients should verify the labeling on their QWIX screws. If the product is labeled as a compression screw, it should not be used for positioning purposes. Consumers should contact their healthcare provider for guidance on the appropriate use of these medical devices.
The recalled product
- Product
- Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 120
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 (20)
- Model Numbers: 121530S
- 121535S
- 121540S
- 121545S
- 121550S
- 121555S
- 121560S
- 121565S
- 121570S
- 121575S
- 121580S
- 121740S
- 121745S
- 121750S
- 121755S
- 121760S
- 121765S
- 121770S
- 121775S
- 121780S
Distribution
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