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Biomet Microfixation, Inc.

40 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blade recall (Z-0843-2012)Biomet Microfixation, Inc.2012-01-24
Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH recall (Z-0835-2012)Biomet Microfixation, Inc.2012-01-23
Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENT recall (Z-0836-2012)Biomet Microfixation, Inc.2012-01-23
The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ recall (Z-0822-2012)Biomet Microfixation, Inc.2012-01-20
The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joi recall (Z-0823-2012)Biomet Microfixation, Inc.2012-01-20
Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RAB recall (Z-0447-2012)Biomet Microfixation, Inc.2012-01-11
Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FR recall (Z-0012-2012)Biomet Microfixation, Inc.2011-10-05
"***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE** recall (Z-2913-2011)Biomet Microfixation, Inc.2011-08-01
"***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") ( recall (Z-2873-2011)Biomet Microfixation, Inc.2011-07-22
"***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUT recall (Z-2849-2011)Biomet Microfixation, Inc.2011-07-19
"***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***K recall (Z-2850-2011)Biomet Microfixation, Inc.2011-07-19
"***REF: 922090 TMJ SYSTEM InnerVue SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***K recall (Z-2851-2011)Biomet Microfixation, Inc.2011-07-19
"***REF: 24-4050 TMJ SYSTEM ArthroSimplicity KIT***STERILE PRODUCT***STERILE EO***KIT CONT recall (Z-2852-2011)Biomet Microfixation, Inc.2011-07-19
Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***J recall (Z-2779-2011)Biomet Microfixation, Inc.2011-07-11
***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 U recall (Z-2385-2011)Biomet Microfixation, Inc.2011-05-27
2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: recall (Z-0108-2011)Biomet Microfixation, Inc.2010-10-20
BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STE recall (Z-2392-2010)Biomet Microfixation, Inc.2010-09-09
BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM T recall (Z-2206-2010)Biomet Microfixation, Inc.2010-08-11
BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X recall (Z-1943-2010)Biomet Microfixation, Inc.2010-06-30
BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEE recall (Z-1319-2010)Biomet Microfixation, Inc.2010-04-11
BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER PO recall (Z-1151-2010)Biomet Microfixation, Inc.2010-03-17
LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, B recall (Z-0489-2010)Biomet Microfixation, Inc.2010-01-04
LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-S recall (Z-0490-2010)Biomet Microfixation, Inc.2010-01-04
Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF recall (Z-0538-2010)Biomet Microfixation, Inc.2009-12-16
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Fra recall (Z-0530-2010)Biomet Microfixation, Inc.2009-12-15
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Fra recall (Z-0531-2010)Biomet Microfixation, Inc.2009-12-15
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Fra recall (Z-0532-2010)Biomet Microfixation, Inc.2009-12-15
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Fra recall (Z-0533-2010)Biomet Microfixation, Inc.2009-12-15
BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Fra recall (Z-0534-2010)Biomet Microfixation, Inc.2009-12-15
Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: R recall (Z-0169-2010)Biomet Microfixation, Inc.2009-11-10
BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP S recall (Z-1949-2009)Biomet Microfixation, Inc.2009-09-08
Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biom recall (Z-1323-2009)Biomet Microfixation, Inc.2009-05-27
REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), recall (Z-0864-2009)Biomet Microfixation, Inc.2009-01-29
REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriver, 1 Tap Handle, 1 Drill Bit, 1 recall (Z-0865-2009)Biomet Microfixation, Inc.2009-01-29
REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypropylene, Radel, AL, SS, T.C. Non recall (Z-0866-2009)Biomet Microfixation, Inc.2009-01-29
REF 01-6851 Office System 1.5/IMF Small Office Set, 156MMX125MM, (6.4"X4.9") Polypropylene recall (Z-0867-2009)Biomet Microfixation, Inc.2009-01-29
Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used recall (Z-0415-2009)Biomet Microfixation, Inc.2008-11-28
HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization a recall (Z-0282-2009)Biomet Microfixation, Inc.2008-11-04
Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915 recall (Z-1872-2008)Biomet Microfixation, Inc.2008-09-16
Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578 recall (Z-1871-2008)Biomet Microfixation, Inc.2008-09-11

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Every clearance here is in the API, with alerts when new ones post.