Z-0544-2015 Class II Terminated
FDA device recall Z-0544-2015 was initiated by Instrumed International, Inc. on September 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements … The recall status is terminated (terminated November 29, 2017). Affected quantity: 16 Hudson burrs.
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
- 16 Hudson burrs
Product Description
Hudson burrs 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, CareFusion, Boss Instruments, and Medline Industries 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 10 mm; Boss Instruments Item Number: 74-0125; Lot Number: 030305. 6) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 14 mm; CareFusion Item Number: H-0343; Lot Numbers: 110212, 120313. 7) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Medline Industries; Medline Industries Product Name: Hudson Burr, 14 mm; Medline Industries Item Number: MDG1199404; Lot Number: 030213. 8) Instrumed Product Name: Hudson Burr, 14 mm; Instrumed Product Number: 600-00561; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 14 mm; Boss Instruments Item Number: 74-0126; Lot Number: 120313. 9) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 600-00566; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 16 mm; Boss Instruments Item Number: 74-0128; Lot Number: 110111. 10) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 22 mm; CareFusion Item Number: VM85-1241; Lot Number: 110212. 11) Instrumed Product Name: Hudson Burr, 22 mm; Instrumed Product Number: 600-00571; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 22 mm; Boss Instruments Item Number: 74-0130; Lot Number: 110212. 12) Instrumed Product Name: Hudson Burr, 16 mm; Instrumed Product Number: 606-00566; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 16 mm; CareFusion Item Number: VM85-12391; Lot Number: 050108.