Recall Z-0557-2015 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Instrumed International, Inc.
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments 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| Reason | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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 | 5 Cloward Spanner gauges |
| 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.