Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL He...
Reason for Recall / Hazard
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Product Description & Identification
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 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
Additional Source Details
| Field | Value |
|---|---|
| City | Hillsboro |
| State | OR |
| Event id | 99123 |
| Address 1 | 5885 NW Cornelius Pass Rd |
| Address 2 | N/A |
| 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 |
| Postal code | 97124-9370 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 5,272 units |
| Reason for recall | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260623 |
Overview
- Recalling FirmAcumed LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.