Use cautionMedical device recall · FDA · Published March 9, 2022
Acumed 4.0mm x 10mm Cannulated Screw Recall: Risk of Bone Fracture
Acumed recalls 4.0mm x 10mm cannulated screws (batch 22 AUG 2018 - 07 FEB 2022) due to potential bone fracture risks. Affected users should contact Acumed for details.
Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Take action
Contact the company
📍Recalling firmAcumed LLC5885 NW Cornelius Pass Rd · Hillsboro, OR 97124-9370
“Acumed 4.0mm x 10mm Cannulated Screw Recall: Risk of Bone Fracture.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60964-acumed-4-0mm-x-10mm-cannulated-screw-recall-risk-of. Based on FDA recall #Z-0958-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0958-2022%22&limit=1).
The FDA announced on March 9, 2022, that Acumed LLC voluntarily recalled 4.0mm x 10mm Cannulated Screws due to insufficient axial pullout strength. This defect poses a risk of bone malunion, fracture, or soft tissue damage.
How to tell if you have it
Brand: Acumed
Product: 4.0mm x 10mm Cannulated Screw, Short Thread
Part number: 3005-40010
Batch numbers: Distributed between 22 AUG 2018 to 07 FEB 2022
UDI: 10806378022869
Units affected: 537
The hazard
The cannulated screws may not have sufficient axial pullout strength for their indicated use. This could result in a malunion or nonunion of bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage.
Context
GovInfoNow's records show Acumed LLC has issued four other recalls since November 29, 2022. Recent brand recalls include a May 28, 2026 recall for hexalob screws due to breakage risk and a December 19, 2023 recall for distribution without pre-market clearance. Other recent recalls of similar products include the Aju Pharm AlternatiV+ Screw-In Anchor Recall (December 17, 2025), the Aju Pharm Genesis Dual Thread Screw-In Anchor Recall (December 17, 2025), and the Genesis Screw-In Anchor Recall (December 17, 2025).
How to tell if you have this one
Check for part number 3005-40010 on the screw packaging. The batch dates range from August 22, 2018, to February 7, 2022. The unique device identifier (UDI) is 10806378022869.
Brand
Acumed
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and the country of South Africa.
Recall number
Product, codes & lots
Quantity
Z-0958-2022
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010; All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869
537 units
Z-0959-2022
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012; All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
506 unit
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the part number (3005-40010) and batch dates (August 22, 2018 - February 7, 2022) on the screw packaging.
Contact Acumed
Reach out to Acumed LLC for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, Puerto Rico and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0958-2022 (March 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0958-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.