| | Class 2 Device Recall Acumed Hexalob Screw |  |
| Date Initiated by Firm | May 28, 2026 |
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| Date Posted | June 23, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2532-2026 |
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| Recall Event ID |
99123 |
| 510(K)Number | K251132 K251296 |
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| Product Classification |
Plate, fixation, bone - Product Code HRS
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| 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 |
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| Code Information |
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
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| FEI Number |
1000125930
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Recalling Firm/
Manufacturer |
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9370
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| For Additional Information Contact | Kathryn Jayne
503-627-9957 Ext. 293 |
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Manufacturer Reason
for Recall | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. |
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FDA Determined
Cause 2 | Device Design |
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| 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 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.
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| Quantity in Commerce | 5,272 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HRS
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