Recall Z-0958-2022— Acumed LLC
Class II · Completed
Class II FDA medical device recall by Acumed LLC, initiated 2022-03-09. It names one FDA 510(k) clearance: K123890. Product: 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010. 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..
- Recalling firm
- Acumed LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-03-09
- Firm location
- Hillsboro, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.