Bone plates and surgical screws distributed without FDA pre-market clearance
Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.
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: These are FDA Class II medical devices distributed without pre-market clearance. While no injuries or illnesses are reported in the source text, the distribution of orthopedic surgical implants without FDA safety verification represents a risk-of-harm situation. Per the rubric, the score is at most 3 since no illnesses or injuries have been reported.
Plain-English summary
Acumed LLC is recalling Acu-Loc and Acu-Loc 2 bone plates, screws, and accessories because they were distributed without FDA pre-market clearance. Approximately 2,952,121 units have been distributed worldwide, including to Australia, Brazil, Canada, France, Germany, India, Japan, Korea, Mexico, and other countries.
The devices were placed on the market without obtaining required FDA pre-market clearance. This means the FDA did not review and verify the safety and effectiveness of these orthopedic surgical devices before their distribution.
Patients and healthcare providers who have these devices should consult with their physician or contact Acumed LLC regarding appropriate next steps.
The recalled product
- Product
- Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate
- Manufacturer
- Acumed LLC
- Hazard
- uncleared-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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