Instrumed Recalls Galt Trephines for Regulatory Compliance Issues
Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by regulatory documentation and marketing history issues rather than a physical defect or reported health hazard, fitting the criteria for Low severity.
Plain-English summary
Instrumed International, Inc. is withdrawing Galt trephines from the market. These are bone cutting and drilling instruments used without a power source on a patient's skull, sold under the CareFusion brand name. The recall involves 3 Galt trephines with the specific product number 600-01091 and lot number 120411.
The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. This is a regulatory compliance issue rather than a report of product malfunction or patient injury.
The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare facilities and consumers who possess these specific instruments should stop using them and contact Instrumed International for further instructions on the withdrawal.
The recalled product
- Product
- Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
- Manufacturer
- Instrumed International, Inc.
- Hazard
- Affected units
- 3
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 (7)
- 1) Instrumed Product Name: Galt Trephine
- 5/8"
- Instrumed Product Number: 600-01091
- Trade Name: CareFusion
- CareFusion Product Name: Galt Trephine
- CareFusion Item Number: VM85-1273
- Lot Number: 120411.
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.
See all 28 products in this recall →Related recalls
Same manufacturer · Instrumed International, Inc.
See all →- LowInstrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Schoitz Weights for Regulatory Compliance Issues
FDA (Devices) · 2014-12-17
Same hazard · regulatory compliance
See all →- HighThomas Scientific Recalls Wuxi Nest Patient Specimen Collection Tubes
FDA (Devices) · 2020-11-25
- ModerateMindray Accutorr 7 Vital Signs Monitor Software Recall
FDA (Devices) · 2019-11-06
- ModerateCOVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve
FDA (Devices) · 2018-12-26
- ModerateFDA Mandates Recall of PremierPro Aluminum Adjustable Walkers
FDA (Devices) · 2018-11-28
- SevereRiddhi USA Inc. Recalls All Dietary Supplements Under Consent Decree
FDA (Food) · 2018-05-09