Universal implant inserters recalled because the rotation tool handle can untread
Medicrea International is recalling 44 IB3D Universal Implant Inserters because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is an inability to rotate the implant, with no patient harm or reported injury.
Plain-English summary
The Medicrea IB3D Universal Implant Inserter, REF A24000000, prescription only, is being recalled by Medicrea International.
Due to complaints, the orthopedic rotation tool handle may untread from the shaft, resulting in the inability to rotate the implant.
The record lists 44 units carrying UDI (01)03613720286677, across lots 21J0410, 21J0414, 21J0418, 25A0023, 21J0466 and 21J1027. Distribution was nationwide in the United States, in Tennessee, California, Minnesota, North Carolina, Texas, Florida, Ohio, Rhode Island and Virginia. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is an inability to rotate the implant, and no injuries are reported. Facilities should quarantine affected stock and follow the firm's instructions.
The recalled product
- Product
- Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Manufacturer
- Medicrea International
- Hazard
- handle-detachment
- instrument-failure
- spinal
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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