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.
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 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
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateIntegra Newdeal SURFIX Screws Recalled for Packaging Labeling Error
FDA (Devices) · 2014-06-11
- HighMedical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
FDA (Devices) · 2024-03-27
- HighBiomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling
FDA (Devices) · 2019-01-16
- ModerateBiomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error
FDA (Devices) · 2014-01-22
- ModerateIntegra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error
FDA (Devices) · 2016-07-06
- ModerateSynthes Recalls 7.0 mm and 7.3 mm Cannulated Screws for Labeling Errors
FDA (Devices) · 2016-07-20