The Recall Desk
HighFDA (Devices)·Z-0958-2022·Announced 2022-04-27

Acumed Cannulated Screws May Lack Sufficient Strength for Bone Fixation

Acumed 4.0mm x 10mm Cannulated Screws may not have sufficient strength to hold bone fragments in place. This could result in improper bone healing, fracture, or soft tissue damage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with potential for serious orthopedic consequences including fracture and joint damage. No illnesses or injuries reported; risk is theoretical. Classified as High per rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Acumed LLC is recalling 4.0mm x 10mm Cannulated Screws (Part number 3005-40010) due to insufficient axial pullout strength for their intended orthopedic use.

The defect may result in malunion (improper bone healing), nonunion (failure of bones to heal), iatrogenic fracture (fracture caused by treatment), joint impingement or damage, or soft tissue damage during or after orthopedic procedures.

The recall affects 537 units distributed nationwide across all U.S. states, Puerto Rico, and South Africa. All batches distributed between August 22, 2018 and February 7, 2022 are included (UDI: 10806378022869).

Healthcare facilities and providers using these screws should discontinue use and contact Acumed LLC regarding return or replacement options.

The recalled product

Product
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Manufacturer
Acumed LLC
Category
Medical Device — Orthopedic / Bone Fixation
Hazard
  • structural-defect
  • fracture-risk
  • joint-damage
  • bone-union-failure

Distribution

Distributed nationwide across the United States.

Related recalls

Same category