[pending] Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Pending LLM rewrite. Source: FDA_DEVICE Z-1039-2026.
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 PL Instruments Set, Rx Only REF: SPS03174
- 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 (20)
- Lot# 0001
- 0002
- 0003
- 0004
- 0005
- 0006
- 0008
- 0009
- 0010
- 0011
- 0012
- 0013
- 0014
- 0016
- 0017
- 0018
- 0020
- 0021
- 0024
- 0025
Distribution
Distributed nationwide across the United States.
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