Recall Z-0553-2015 ยท HAX Tong, Skull For Traction
Instrumed International, Inc.
Titanium fixation screws, 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 Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand names.
| Date | Dec 16, 2014 (initiated Sep 8, 2014) |
| Status | Terminated |
| Reason | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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. |
| Root cause | No Marketing Application |
| Action | Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119. |
| Quantity | 22 titanium fixation screws, springloaded |
| Distribution | Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.