[pending] Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Pending LLM rewrite. Source: FDA_DEVICE Z-1038-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
The recalled product
- Product
- Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Manufacturer
- Medicrea International
- Category
- Medical Device — Devices
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 (6)
- Lot# 21J0410
- 21J0414
- 21J0418
- 25A0023
- 21J0466
- 21J1027/ UDI: (01)03613720286677
Distribution
Distributed nationwide across the United States.
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