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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 506
Distribution
Part of a larger recall action
This product is one of 2 recalled by Acumed LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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