openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17279012 UDI: (01)4546540039415
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 2 of 13
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Numbers: 17277012, 17283012 UDI: (01)4546540857880
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 3 of 13
1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number (Medium): 17276012; Lot Number (Large): 17282012 UDI: (01)4546540039552; (01)4546540039569
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 4 of 13
1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012 UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17278012 UDI: (01)7613252594307
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 7 of 13
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17277012 UDI: (01)4546540907035
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17293012 UDI: (01)4546540911971
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17290012 UDI: (01)4546540912114
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 11 of 13
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17283012 UDI: (01)7613252029830
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 12 of 13
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
device · product 13 of 13
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Code information
Lot Number: 17284012 UDI: (01)4546540255853
Distribution pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
