Recall Z-0958-2022 ยท HWC Screw, Fixation, Bone
Acumed LLC
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
| Date | Mar 9, 2022 |
| Status | Completed |
| Reason | 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. |
| Root cause | Device Design |
| Action | Urgent Medical Device recall notice dated 3/8/22 was send out to customers via mail. Special Instructions: IMMEDIATELY stop using and/or distributing the product and complete the following actions 1) Perform a physical count of your inventory. 2) Remove the affected product, such that they are out of service. 3) Record this data on the survey and Return the survey via email to RecallNotification@acumed.net. 4) To facilitate return of product. a) Independent Sales Consultants: contact Agent Inventory via email at agentinventory@acumed.net b) Domestic Direct Customers: contact Business Servic |
| Quantity | 537 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123890 | ACUMED CANNULATED SCREW SYSTEM Acumed, LLC, Mar 18, 2013 |