Home / Recalls / Instrumed International, Inc. / Z-0554-2015

Z-0554-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
September 8, 2014
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 traction tong replacement screws, non-springloaded

Product Description

Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.

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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Distribution Pattern

Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Code Information

1) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Fixation Screw Non-Springloaded; CareFusion Item Number: NL9514-T; Lot Number: 100512. 2) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Boss Instruments; Boss Instruments Product Name: Replacement Screw Non-Springloaded, Traction Tong; Boss Instruments Item Number: 74-0185T; Lot Numbers: 020512, 100512, 110211. 3) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Replacement Screw Non-Springloaded, Traction Tong; Stealth Surgical Item Number: SS2193BT; Lot Numbers: 070312. 4) Instrumed Product Name: Replacement Screw Non-Springloaded, Traction Tong; Instrumed Product Number: 638-05429; Trade Name: CareFusion; CareFusion Product Name: Replacement Screw Non-Springloaded, Traction Tong; CareFusion Item Number: VM85-12965; Lot Numbers: 100512, 110211.

Other recalls by Instrumed International, Inc.

  • Z-0550-2015 Class II — Gardner-Wells traction tongs are skull tongs for traction used to immobilize a p (September 8, 2014)
  • Z-0559-2015 Class II — Schoitz weights are manual devices used with Schoitz tonometers and are intended (September 8, 2014)
  • Z-0533-2015 Class II — An endometrial suction curette is a device used to remove material from the uter (September 8, 2014)
  • Z-0532-2015 Class II — A uterine tenaculum is a hook-like instrument used to seize and hold the cervix (September 8, 2014)
  • Z-0544-2015 Class II — Hudson burrs are bone cutting and drilling instruments that are used without a p (September 8, 2014)
  • Z-0534-2015 Class II — A zipser clamp is an instrument used to compress reduce blood flow to the penis (September 8, 2014)
  • Z-0538-2015 Class II — A circumcision clamp is an instrument used to compress the foreskin of the penis (September 8, 2014)
  • Z-0541-2015 Class II — Hudson cerebellar extensions are bone cutting and drilling instruments that are (September 8, 2014)
  • Z-0549-2015 Class II — Galt trephines are bone cutting and drilling instruments that are used without a (September 8, 2014)
  • Z-0535-2015 Class II — A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel (September 8, 2014)