Acumed Hexalob Screws Recall Due to Breakage Risk
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Acumed LLC is recalling 5,272 units of various Hexalob screws after a manufacturing error may cause them to break during use with wrist fixation systems.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Acumed LLC is recalling certain hexalobe screws used with wrist fixation systems because a manufacturing error may cause the screws to break during use.
Which Products Are Affected
The recall covers Acumed Hexalob Screw various sizes with the following REF numbers: 3070-27008, 3070-27009, 3070-27010, 3070-27011, 3070-27012, 3070-27013, 3070-27014, 3070-27015, 3070-27016, 3070-27017, 3070-27018, 3076-30010, 3076-30012, and 3076-30014. Specific lots and UDI numbers are listed in FDA recall Z-2532-2026. A total of 5,272 units are affected. Distribution was nationwide across 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, and WI.
What You Should Do
Consumers and healthcare providers should follow instructions provided by Acumed LLC regarding the recalled devices.
Why This Matters
The Class II recall involves devices that may cause temporary or reversible adverse health consequences if the screws break during surgical use.
Source
FDA recall Z-2532-2026. https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,077 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.