Gardner-Wells wrenches withdrawn for pre-amendment regulatory non-compliance
Instrumed International is withdrawing Gardner-Wells wrenches because they were not marketed prior to September 26, 1976, and do not 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 due to a documentation and regulatory compliance issue regarding pre-amendment status, with no reported injuries or safety hazards, fitting the Low severity criteria for documentation issues.
Plain-English summary
Instrumed International, Inc. is withdrawing Gardner-Wells wrenches from the market. These devices are used in traction skull tongs to immobilize patients with cervical spine injuries and are sold under the CareFusion brand name. The recall involves two specific wrenches, identified by Instrumed Product Number 638-05441 and Lot Number 011112, with CareFusion Item Numbers VM85-12015 and NL9516-T.
The reason for this withdrawal is that Instrumed did not market these devices prior to September 26, 1976. Consequently, the devices do not meet all FDA requirements to be marketed as "Pre-Amendment" devices. This is a regulatory compliance issue rather than a report of a specific safety defect or injury.
The devices were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Users should contact Instrumed International for further instructions regarding the withdrawal of these specific items.
The recalled product
- Product
- Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 2
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: Gardner-Wells Titanium Wrench 1/2"
- Instrumed Product Number: 638-05441
- Trade Name: CareFusion
- CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2"
- CareFusion Item Number: VM85-12015
- CareFusion Item Number: NL9516-T
- Lot Number: 011112.
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
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