Instrumed International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0548-2015)

Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.

Class II

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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

1) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Symmetry Surgical Item Number: 57-6000; Lot Number: 110212. 2) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Medfix International; Medfix International Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Medfix International Item Number: MF223-1672; Lot Number: 110212. 3) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Stealth Surgical Item Number: SS2135; Lot Number: 110212. 4) Instrumed Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Instrumed Product Number: 600-00616; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Cranial Drill Set (w/ brace and 5 attachments); Boss Instruments Item Number: 74-0120; Lot Numbers: 030112, 110212.

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

Voluntary: Firm initiated