Replacement screw non-springloaded 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 CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Fixation Screws Fixation Screw Non-Springloaded; CareFusion Item Number: NL9506; Lot Numbers: 010113, 020512, 050514, 060213, 070213, 070413, 120413. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180; Boss Instruments Item Number: 74-0185; Lot Numbers: 010113, 020512, 060213, 120413. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Millennium Surgical Item Number: 6-1948; Lot Numbers: 020512, 070213, 120413. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Prezio Health; Prezio Health Product Name: Replacement Screw Non-Springloaded, Traction Tong; Prezio Health Item Number: 85-1296; Lot Number: 020512. 5) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193B; Lot Numbers: 020512, 120413. 6) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-1296; Lot Numbers: 010113, 010412, 020512.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Instrumed International, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Replacement screw non-springloaded 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 CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical brand names.
Product Codes/Lot Numbers:
1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Gardener-Wells Fixation Screws Fixation Screw Non-Springloaded; CareFusion Item Number: NL9506; Lot Numbers: 010113, 020512, 050514, 060213, 070213, 070413, 120413. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded for 74-0180; Boss Instruments Item Number: 74-0185; Lot Numbers: 010113, 020512, 060213, 120413. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Millennium Surgical Item Number: 6-1948; Lot Numbers: 020512, 070213, 120413. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Prezio Health; Prezio Health Product Name: Replacement Screw Non-Springloaded, Traction Tong; Prezio Health Item Number: 85-1296; Lot Number: 020512. 5) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193B; Lot Numbers: 020512, 120413. 6) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 630-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-1296; Lot Numbers: 010113, 010412, 020512.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0551-2015
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