Z-0958-2022Class II

4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010

Name: Z-0958-2022 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Creator: Acumed LLC
Published: 2022-03-09
License: https://open.fda.gov/license/

Acumed LLC / initiated 2022-03-09 / Completed / root cause: design

FDA source

Acumed LLC began a recall of 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 on 2022-03-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0958-2022
Classification: Class II
Status: Completed
Initiated: 2022-03-09
Posted: 2022-04-20
Recalling firm: Acumed LLC
Product: 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: design
FDA 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 [email protected]. 4) To facilitate return of product. a) Independent Sales Consultants: contact Agent Inventory via email at [email protected] b) Domestic Direct Customers: contact Business Services via email at [email protected] 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 [email protected] 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 [email protected] 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: 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.
Product codes and lots: All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-27	2022-04-20
Z-0959-2022	Class II	Completed	Voluntary: Firm initiated	2022-04-27	2022-04-20

Product code HWC

K123890Class IIAcumed Cannulated Screw SystemAcumed, LLC / cleared 2013-03-18

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)