Spinal instrument sets recalled because the rotation tool handle can untread
Medicrea International is recalling 44 IB3D PL Instruments Sets because, following complaints, the orthopedic rotation tool handle may untread from the shaft.
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 2/5 (Moderate).
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 PL Instruments Set, REF SPS03174, 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 across lots including 0001 through 0020 as recorded in the enforcement record. 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 sets and follow the firm's instructions.
The recalled product
- Product
- Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- Manufacturer
- Medicrea International
- Affected units
- 44
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
Part of a larger recall action
This product is one of 2 recalled by Medicrea International 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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