Quick Facts at a Glance
- Recall Date
- May 28, 2026
- Hazard Level
- HIGH
- Brand
- Acumed
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Acumed
- Model numbers
- 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 +12 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 28, 2026
Reported by FDA DEVICE
July 1, 2026
RecallRadar source check
July 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Acumed LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Full Description
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; 3070-27013 2.7mm x 13mm NL Hexalobe Screw; 3070-27014 2.7mm x 14mm NL Hexalobe Screw; 3070-27015 2.7mm x 15mm NL Hexalobe Screw; 3070-27016 2.7mm x 16mm NL Hexalobe Screw; 3070-27017 2.7mm x 17mm NL Hexalobe Screw; 3070-27018 2.7mm x 18mm NL Hexalobe Screw; 3076-30010 3.0mm x 10mm NL Hexalobe Screw; 3076-30012 3.0mm x 12mm NL Hexalobe Screw; 3076-30014 3.0mm x 14mm NL Hexalobe Screw. Reason: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.. Classification: Class II. Quantity: 5,272 units. Distribution: US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.
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Safety Guide
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Read: How to Get Refunds and ReplacementsWant to Know First?
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