Z-2532-2026Class II

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm...

Name: Z-2532-2026 Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm...
Creator: Acumed LLC
Published: 2026-05-28
License: https://open.fda.gov/license/

Acumed LLC / initiated 2026-05-28 / Open, Classified / root cause: design

FDA source

Acumed LLC began a recall of 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... on 2026-05-28. FDA classified it as Class II and gives the reason as "Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2532-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-28
Posted: 2026-06-23
Recalling firm: Acumed LLC
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Root cause tag: design
FDA 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 [email protected] 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.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2532-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2532-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-23

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)