Biomet Microfixation, Inc. Recalls

All product recalls associated with Biomet Microfixation, Inc..

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Recall Summary

Total Recalls

18

Past Year

0

Class I (Serious)

0

Most Recent

Nov 2009

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–18 of 18 recalls

Biomet Microfixation, Inc.: Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYST...

The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).

FDANov 6, 2009Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF...

Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.

FDAOct 6, 2009Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TO...

Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

FDAOct 5, 2009CA, CO, MI +1 more• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF:...

Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.

FDASep 15, 2009FL, KS, MO• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR P...

Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.

FDASep 15, 2009FL, KS, MO• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Lactosorb Pectus Stabilizer, model number: 01-3805. Distr...

This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction.

FDAMar 20, 2009AL, AZ, CA +25 more• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product lab...

Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.

FDAFeb 19, 2009AZ, CA, GA +7 more• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DR...

Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe

FDAFeb 16, 2009Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: BD Recalled component is labeled: BD 60ml Syringe Luer-...

Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ

FDAJan 9, 2009AL, CA, CT +22 more• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Fredrick's Converse Retractor #5 F/O, Model Number: 01-04...

Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

FDAOct 24, 2008Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypr...

Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

FDAAug 6, 2008PR• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriv...

Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

FDAAug 6, 2008PR• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Comp...

Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

FDAAug 6, 2008PR• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: REF 01-6851 Office System 1.5/IMF Small Office Set, 156...

Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.

FDAAug 6, 2008PR• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Sc...

The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.

FDAJul 11, 2008Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ...

The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.

FDAMay 21, 2008Nationwide• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model num...

The working tips of the Stella Osteotomes are thicker than specification.

FDAApr 16, 2008MO, NM, TX• Biomet Microfixation, Inc.

Biomet Microfixation, Inc.: Lactosorb Trauma Plating System, part numbers: 915-2100, ...

The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).

FDAMar 19, 2008CA, GA, HI +5 more• Biomet Microfixation, Inc.

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Biomet Microfixation, Inc. Recalls

Recall Summary

Biomet Microfixation, Inc.: Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYST...

Biomet Microfixation, Inc.: BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF...

Biomet Microfixation, Inc.: BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TO...

Biomet Microfixation, Inc.: LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF:...

Biomet Microfixation, Inc.: LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR P...

Biomet Microfixation, Inc.: Lactosorb Pectus Stabilizer, model number: 01-3805. Distr...

Biomet Microfixation, Inc.: Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product lab...

Biomet Microfixation, Inc.: BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DR...

Biomet Microfixation, Inc.: BD Recalled component is labeled: BD 60ml Syringe Luer-...

Biomet Microfixation, Inc.: Fredrick's Converse Retractor #5 F/O, Model Number: 01-04...

Biomet Microfixation, Inc.: REF: 01-6871 IMF Set 254 X 127 X34MM (10"X1"X1.2") Polypr...

Biomet Microfixation, Inc.: REF: 915-1000 Lactosorb, Office Fixation Kit, 1 Screwdriv...

Biomet Microfixation, Inc.: REF: 915-1006 Lactosorb System, Lacto Endobrow Lift Comp...

Biomet Microfixation, Inc.: REF 01-6851 Office System 1.5/IMF Small Office Set, 156...

Biomet Microfixation, Inc.: HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Sc...

Biomet Microfixation, Inc.: Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ...

Biomet Microfixation, Inc.: Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model num...

Biomet Microfixation, Inc.: Lactosorb Trauma Plating System, part numbers: 915-2100, ...