Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance
Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.
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 1/5 (Low).
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 compliance and documentation issues regarding pre-amendment status, with no reported injuries, illnesses, or functional defects cited in the source text.
Plain-English summary
Instrumed International, Inc. is voluntarily withdrawing 190 Gardner-Wells traction tongs from the market. These skull tongs are used to immobilize patients with cervical spine injuries, such as fractures or dislocations. The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
The reason for this withdrawal is that Instrumed did not market these specific devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. The recall covers various product configurations, including complete tongs and titanium small, medium, and large opening sizes, sold under multiple brand names such as Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments.
Healthcare facilities and distributors should stop using the affected units and contact Instrumed International for instructions on returning the devices. Consumers should not use these products and should contact their healthcare provider or the manufacturer for further guidance.
The recalled product
- Product
- Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss…
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 190
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: Gardner-Wells Traction Tongs Complete
- Instrumed Product Number: 630-05401
- Trade Name: Millenium Surgical
- Millenium Surgical Product Name: Gardner-Wells Traction Tongs Complete
- Millenium Surgical Item Number: 12-661025
- Lot Numbers: 040313
- 070512. 2) Instrumed Product Name: Gardner-Wells Traction Tongs Complete
- Trade Name: Echo Instruments
- Echo Instruments Product Name: Gardner-Wells Traction Tongs Complete
- Echo Instruments Item Number: 576-804
- Lot Numbers: 050413
- 110212. 3) Instrumed Product Name: Gardner-Wells Traction Tongs Complete
- Millenium Surgical Item Number: 6-1945
- Lot Numbers: 030314
- 040313
- 050413
- 110212. 4) Instrumed Product Name: Gardner-Wells Traction Tongs Complete
- Trade Name: Adler Instrument
- Adler Instrument Product Name: Gardner-Wells Traction Tongs Complete
- Adler Instrument Item Number: ADR1945
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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