Recall Z-2532-2026 ยท HRS Plate, Fixation, Bone
Acumed LLC
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; 3070-27
| Date | Jun 23, 2026 (initiated May 28, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. |
| Root cause | Device Design |
| Action | On May 28, 2026 Acumed issued a Urgent Medical Device Recall Notification to affected consignees via phone calls and email. Acumed asked consignees to take the following actions: 1)IMMEDIATELY stop using and/or distributing the product and complete the following actions: 2) Perform a physical count of your inventory. Identify any inventory of the batch/lot numbers listed in the table above. 3) Remove the product segregated in step 1, such that they are taken out of service (i.e., quarantined). 3) Verbally acknowledge (then respond via email) to Kathryn.jayne@acumed.net the recall notice. |
| 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. |
| FDA record | Open on fda.gov |