4.0mm x 10mm Cannulated Screw recall
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Why was 4.0mm x 10mm Cannulated Screw 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Batch number distributed between 22 AUG 2018 to 07 FEB 2022 . UDI : 10806378022869
- Product
- 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
- Recalling firm
- Acumed LLC
- 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.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)