Acumed Hexalob Screw various sizes recallZ-2532-2026 · Acumed LLC · initiated May 28, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Acumed LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
FDA root cause category: Device Design
What the company 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 [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.
Recall details
- Recall number
- Z-2532-2026
- Status
- Open, Classified
- Initiated by the company
- May 28, 2026
- Posted by the FDA
- Jun 23, 2026
- Recalling firm
- Acumed LLC
- Quantity
- 5,272 units
- Product code
- HRS
- FDA submissions
- K251132, K251296
- 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 description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- ACUMED 3070-27014Acumed LLC · Screw, fixation, bone1 recall3 reports
- ACUMED 3070-27015Acumed LLC · Screw, fixation, bone1 recall3 reports
- ACUMED 3070-27016Acumed LLC · Screw, fixation, bone1 recall2 reports
- ACUMED 3070-27013Acumed LLC · Screw, fixation, bone1 recall1 report
- ACUMED 3070-27008Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27009Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27010Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27011Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27012Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27017Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3070-27018Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3076-30010Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3076-30012Acumed LLC · Screw, fixation, bone1 recall0 reports
- ACUMED 3076-30014Acumed LLC · Screw, fixation, bone1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K251132, K251296 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ACUMED 3065-20016Acumed LLC · Screw, fixation, bone1 report
- ACUMED 3067-24014Acumed LLC · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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