The Recall Desk
HighFDA (Devices)·Z-0959-2022·Announced 2022-04-27

Acumed Cannulated Screws Recalled for Insufficient Axial Pullout Strength

Acumed LLC is recalling Cannulated Screws (4.0mm x 12mm) that may not have sufficient strength to hold bone fragments together, risking fracture or joint 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: This is an FDA Class II medical device recall with potential for serious harm (fracture, joint damage, soft tissue injury), but no reported illnesses or injuries. The hazard is characterized as a remote possibility, making this at most a High severity per the rubric for theoretical risks.

Plain-English summary

Acumed LLC is recalling Cannulated Screws (Part number 3005-40012), 4.0mm x 12mm due to insufficient axial pullout strength. A total of 506 units were distributed between August 22, 2018 and February 7, 2022.

The screws may not have sufficient strength for their intended use. This could result in malunion or nonunion of bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. The possibility of harm is remote.

The affected units were distributed in all US states, Puerto Rico, and South Africa. Facilities or individuals who possess these screws should contact Acumed LLC regarding the recall.

The recalled product

Product
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Manufacturer
Acumed LLC
Category
Medical Device — Orthopedic Screw
Hazard
  • structural-defect
  • malunion-nonunion
  • fracture
  • joint-damage
  • soft-tissue-damage

Distribution

Distributed nationwide across the United States.

Related recalls

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