medical MODERATE Updated 2026-07-01

Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-270

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Recalled 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; 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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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; 3070-27018/Lot: 667169, 668260, 682482/UDI: 10806378126093; 3076-30010/Lots: 667202, 668271/UDI: 10806378126109; 3076-30012/Lots: 667242, 668273/UDI: 10806378126116; 3076-30014/Lots: 667205, 668272/UDI: 10806378126123

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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