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Exactech, Inc.

134 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-0 recall (Z-0906-2015)Exactech, Inc.2015-01-05
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number recall (Z-2086-2014)Exactech, Inc.2014-07-21
Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and recall (Z-1217-2014)Exactech, Inc.2014-03-18
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXAC recall (Z-0906-2014)Exactech, Inc.2014-02-03
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to recall (Z-1832-2013)Exactech, Inc.2013-07-31
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, si recall (Z-0953-2013)Exactech, Inc.2013-03-15
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 012345 recall (Z-0787-2013)Exactech, Inc.2013-02-05
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, S recall (Z-0788-2013)Exactech, Inc.2013-02-05
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Sc recall (Z-2361-2012)Exactech, Inc.2012-09-11
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Sc recall (Z-2362-2012)Exactech, Inc.2012-09-11
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Sc recall (Z-2363-2012)Exactech, Inc.2012-09-11
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Sc recall (Z-2364-2012)Exactech, Inc.2012-09-11
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Sc recall (Z-2365-2012)Exactech, Inc.2012-09-11
REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Sc recall (Z-2366-2012)Exactech, Inc.2012-09-11
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, recall (Z-2310-2012)Exactech, Inc.2012-09-04
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***M recall (Z-2234-2012)Exactech, Inc.2012-08-21
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthrop recall (Z-2115-2012)Exactech, Inc.2012-07-31
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arth recall (Z-2116-2012)Exactech, Inc.2012-07-31
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthrop recall (Z-2117-2012)Exactech, Inc.2012-07-31
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Tot recall (Z-2118-2012)Exactech, Inc.2012-07-31
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder recall (Z-2119-2012)Exactech, Inc.2012-07-31
Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body fus recall (Z-2120-2012)Exactech, Inc.2012-07-31
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** recall (Z-2070-2012)Exactech, Inc.2012-07-24
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy recall (Z-2071-2012)Exactech, Inc.2012-07-24
Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, recall (Z-0572-2008)Exactech, Inc.2008-03-12
AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Se recall (Z-0916-2007)Exactech, Inc.2007-06-09
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component recall (Z-0522-2007)Exactech, Inc.2007-02-27
Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 recall (Z-0196-2007)Exactech, Inc.2006-11-21
Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is lab recall (Z-0927-06)Exactech, Inc.2006-06-02
The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL recall (Z-1379-05)Exactech, Inc.2005-08-18
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/pol recall (Z-0347-05)Exactech, Inc.2004-12-23
Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIV recall (Z-0105-04)Exactech, Inc.2003-11-11
Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta a recall (Z-1211-03)Exactech, Inc.2003-09-11
Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-7 recall (Z-1146-03)Exactech, Inc.2003-08-26
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Every clearance here is in the API, with alerts when new ones post.