Gardner-Wells wrenches are used in traction recall
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…
Why was Gardner-Wells wrenches are used in traction recalled?
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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; Lot Number: 011112. 2) 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: NL9516-T; Lot Number: 011112.
- 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…
- Recalling firm
- Instrumed International, Inc.
- Quantity
- 2 Gardner-Wells wrenches
- Distribution
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)