Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL H
FDA device recall Z-2532-2026 · posted 2026-06-23 · Open, Classified
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
- Action taken
- 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. 4) You will be contacted by Field Inventory department who will directly remove the screws and conduct a count reconciliation. 5) This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 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.
- Date initiated
- 2026-05-28
- Date posted
- 2026-06-23
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws (K251132) | Acumed, LLC | 2025-07-14 |
| The Acumed Wrist Fixation System (K251296) | Acumed, LLC | 2025-06-18 |