Data Foundry

Medical device recalls 2026

Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2 — Class II medical device recall Z-2532-2026

Ongoing recall by Acumed LLC, reported 2026-07-01, distributed nationwide. Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Recall numberZ-2532-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAcumed LLC, Hillsboro, OR, United States
Recall initiated2026-05-28
Classified2026-06-23
Reported by FDA2026-07-01
DistributedNationwide (US)
Quantity5,272 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI10806378125997, 10806378126000, 10806378126017, 10806378126024, 10806378126031, 10806378126048, 10806378126055, 10806378126062, 10806378126079, 10806378126086, 10806378126093, 10806378126109, 10806378126116, 10806378126123
Lot numbers667169, 667202, 667205, 667231, 667233, 667236, 667237, 667242, 668260, 668261, 668266, 668269, 668271, 668272, 668273, 668704, 668705, 668706, 680400, 680621, 680737, 680797, 680935, 680936, 681575, 682194, 682195, 682390, 682482
Model numbers2.7MM, 3070-27008, 8MMNL

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

Reason for recall

Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2532-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.