FDA Medical Device Recalls (openFDA)
Acumed LLC: 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
- Recall number
- Z-0959-2022
- Recalling firm
- Acumed LLC
- Product
- 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
- Status
- Completed
- Initiated
- 2022-03-09
- Posted
- not on file
- Terminated
- not on file
- 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 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
- 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.
- Lot, serial or model codes
- All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876
- 510(k) numbers
- ["K123890"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 1000125930
- Firm city
- Hillsboro
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28