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FDA-Device2026-07-01Class IIPROCESSING DEFECT

Acumed Hexalob Screws recalled for potential breakage during wrist fixation

Acumed
OTHERNationwide distributiondevice

Acumed Hexalob Screws recalled for breakage risk

Acumed Hexalob Screws used in wrist fixation systems may break during use due to a manufacturing error. The affected screws come in various sizes (2.7mm and 3.0mm) and have been distributed nationwide. No injuries have been reported.

  • Check if you have received any of the affected screw sizes listed in the recall notice
  • Contact Acumed or your healthcare provider for guidance on inspection or replacement
  • Do not use affected screws in wrist fixation procedures until you receive further instructions
Hazard

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Who it affects
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
5,272 units
Manufactured in
5885 NW Cornelius Pass Rd, N/A, Hillsboro, OR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2026

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