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4.0mm x 12mm Cannulated Screw, Short Thread recallZ-0959-2022 · Acumed LLC · initiated Mar 9, 2022

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Acumed LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-0959-2022
Status
Completed
Initiated by the company
Mar 9, 2022
Recalling firm
Acumed LLC
Quantity
506 unit
Product code
HWC
FDA submissions
K123890
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 description

4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012

Code information (models, lots, serial numbers)

All Batch numbers distributed between 22 AUG 2018 to 07 FEB 2022. UDI:10806378022876

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 89771).

Sources and updates

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