Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe…
Reason for recall
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw
- 27009 2.7mm x 9mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27010 2.7mm x 10mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27011 2.7mm x 11mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27012 2.7mm x 12mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27013 2.7mm x 13mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27014 2.7mm x 14mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27015 2.7mm x 15mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27016 2.7mm x 16mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27017 2.7mm x 17mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 27018 2.7mm x 18mm NL Hexalobe Screw3070UDI 108063781260933 affected lots66716966826010806378126093
- 30010 3.0mm x 10mm NL Hexalobe Screw3076UDI 108063781261232 affected lots66720510806378126123
- 30012 3.0mm x 12mm NL Hexalobe Screw3076UDI 108063781261232 affected lots66720510806378126123
- 30014 3.0mm x 14mm NL Hexalobe Screw3076UDI 108063781261232 affected lots66720510806378126123
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2532-2026
- FDA 510(k) clearance · K251132The device's official FDA premarket clearance record
- FDA 510(k) clearance · K251296The device's official FDA premarket clearance record
- FDA device classification · HRSOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3030The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Acumed LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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