Class 2 Device Recall Acumed Cannulated Screw System

• Date Initiated by Firm: March 09, 2022
• Create Date: April 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0959-2022
• Recall Event ID: 89771
• 510(K)Number: K123890
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
• Code Information: All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
• Recalling Firm/ Manufacturer: Acumed LLC; 5885 NW Cornelius Pass Rd; Hillsboro OR 97124-9370
• For Additional Information Contact: Kathryn A. Jayne; 972-677-4766
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 Services via email at businessservices@acumed.net or contact your agent directly to be assigned a Return Material Authorization number and applicable shipping information. c)International Customers: contact Business Services via email internationalbusinessservices@acumed.net or via phone at (888) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) to be assigned a RMA number and applicable shipping information. 6) Once completed, please return the affected product using the Return Label. For patients implanted with these affected devices, firm advises physicians to monitor patients. The implanting and treating physicians are in the best position to exercise medical judgment for their patients and should make the final decision on indications for additional treatment depending on the patient s symptoms. Physicians are urged to notify of any adverse events or product safety issues. Please note that this recall extends to the user level. If you have distributed the affected product, please notify your consignees about this issue and ensure that any inventory is taken out of service. Please contact Business Services via email at BusinessServices@acumed.net or via phone at (888) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) with any questions regarding this notification.
• Quantity in Commerce: 506 unit
• 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.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = HWC and Original Applicant = ACUMED LLC