Instrumed Recalls Manual Trephines for Regulatory Compliance
Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.
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: The recall is a voluntary precautionary withdrawal due to regulatory compliance issues regarding pre-amendment status, with no reported injuries or illnesses.
Plain-English summary
Instrumed International, Inc. is withdrawing 74 manual trephines from the market. These bone cutting and drilling instruments are used without a power source on a patient's skull and are sold under the brand names Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct.
The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976, and therefore does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The affected units were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
No specific consumer action is detailed in the source text beyond the withdrawal of the devices from the market.
The recalled product
- Product
- Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
- Manufacturer
- Instrumed International, Inc.
- Hazard
- Affected units
- 74
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)
- 1) Instrumed Product Name: Michele Trephine
- 6 1/4"
- shaft
- 3/16" OD
- Instrumed Product Number: 590-06491
- Trade Name: Millennium Surgical
- Millennium Surgical Product Name: Michele Trephine
- Millennium Surgical Item Number: 0-48239
- Lot Numbers: 020212
- 120312. 2) Instrumed Product Name: Michele Trephine
- Trade Name: Symmetry Surgical
- Symmetry Surgical Product Name: Michele Trephine
- Symmetry Surgical Item Number: 57-6305
- 100111
- 100213
- 120312. 3) Instrumed Product Name: Michele Trephine
- Trade Name: Medline Industries
- Medline Industries Product Name: Michele Trephine
- Medline Industries Item Number: MDG1806301
- 100111. 4) Instrumed Product Name: Michele Trephine
Distribution
Part of a larger recall action
This product is one of 28 recalled by Instrumed International, Inc. 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.
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