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
Acumed LLC
The hazard
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 3070-27008/Lots: 668261/UDI: 10806378125997Model 3070-27009/Lots: 680797/UDI: 10806378126000Model 3070-27010/Lots: 667231Model 682194/UDI: 10806378126017Model 3070-27011/Lots: 680621Model 680737/UDI: 10806378126024Model 3070-27012/Lots: 667233Model 668266Model 668704Model 682195/UDI: 10806378126031Model 3070-27013/Lots:668706Model 680400/UDI: 10806378126048Model 3070-27014/Lots: 667236Model 668705Model 680935/UDI: 10806378126055Model 3070-27015/Lots: 667237Model 680936/UDI: 10806378126062Model 3070-27016/Lots: 668269Model 682390/UDI: 10806378126079Model 3070-27017/Lot: 681575/UDI: 10806378126086Model 3070-27018/Lot: 667169Model 668260Model 682482/UDI: 10806378126093Model 3076-30010/Lots: 667202Model 668271/UDI: 10806378126109UPC 10806378125997UPC 10806378126000UPC 10806378126017UPC 10806378126024UPC 10806378126031UPC 10806378126048UPC 10806378126055UPC 10806378126062UPC 10806378126079UPC 10806378126086UPC 10806378126093UPC 10806378126109UPC 10806378126116UPC 10806378126123Would you have heard about this one?
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