Acumed Hexalob Screws Recalled for Risk of Fracture During Use
Acumed LLC is recalling Hexalob Screws of various sizes used with wrist fixation systems due to a manufacturing error that may cause the screws to break during use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a structural/mechanical failure of an orthopedic implant screw that poses a risk of harm (fracture during use) if the device fails. No reported illnesses or injuries are stated in the source text, which limits the score below 4; however, the hazard is not merely theoretical—it is a specific manufacturing defect with direct potential for patient harm, placing it at score 3.
Plain-English summary
Acumed LLC is recalling Acumed Hexalob Screws in multiple sizes (ranging from 2.7mm and 3.0mm diameter with lengths from 8mm to 18mm) due to a manufacturing error. These screws are used as part of wrist fixation systems and may break during use, which could compromise the stability of the fixation device and patient outcomes.
The recalled products were distributed nationwide across 25 states: AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI. A total of 5,272 units have been identified in this recall.
Patients or healthcare providers who have received or used these screws should contact Acumed LLC or the healthcare facility where the device was implanted to discuss appropriate follow-up. Patients experiencing symptoms related to fixation failure should seek medical attention immediately. The FDA's recall number is Z-2532-2026.
The recalled product
- Product
- Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw…
- Manufacturer
- Acumed LLC
- Affected units
- 5,272
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)
- 3070-27008/Lots: 668261/UDI: 10806378125997
- 3070-27009/Lots: 680797/UDI: 10806378126000
- 3070-27010/Lots: 667231
- 682194/UDI: 10806378126017
- 3070-27011/Lots: 680621
- 680737/UDI: 10806378126024
- 3070-27012/Lots: 667233
- 668266
- 668704
- 682195/UDI: 10806378126031
- 3070-27013/Lots:668706
- 680400/UDI: 10806378126048
- 3070-27014/Lots: 667236
- 668705
- 680935/UDI: 10806378126055
- 3070-27015/Lots: 667237
- 680936/UDI: 10806378126062
- 3070-27016/Lots: 668269
- 682390/UDI: 10806378126079
- 3070-27017/Lot: 681575/UDI: 10806378126086
Distribution
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