2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 2879138 2879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 2879441 2879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 2879450 2879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 2879459 2886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 2886788 2886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 2886957 2886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 2962286 2962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 2963825 2963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 2963914 2963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 2963993 2963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 2965902 2965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 2965911 2965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 2974862 2974863 2974864 2974865 2974866 2974867 2974868 2974869 2974870 3021827 3021829 3021830 3021831 3021832 3021833 3021834 3021836 3021877 3021878 3021882 3021883 3021885 3023281 3023282 3023283 3023284 3023285 3023286 3023287 3023288 3023289 3030571 3030572 3030573 3030574 3031471 3031473 3031474 3031475 3031476 3031477 3031478 3031479 3031480

Orthopedic Devices

2

Yes

Products were distributed worldwide.

Product is 1.0 cc Regenaform¿ RT. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

part number: 456.316S, lot number: 7782247

Orthopedic Devices

2

Yes

US Distribution in the states of: AK, FL, OH, OK, and TX.

10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur

No code information applies.

Orthopedic Devices

2

Yes

AZ, ID, TX CTdistributors.

17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. || Part of the ''RT/RT Modular'' total knee replacement.

Lot Number: 08060305

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS

Part Number 202.212 Lot Number 3420620

Orthopedic Devices

2

Yes

US Distribution to the state of : TN

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.

Catalog/model numbers: 02.123.020, 02.123.020S, 02.123..021, 02.123.021S, 02.123.022, 02.123.022S, 02.123.023, 02.123.023S, 02.123.024, 02.123.024S, 02.123.025, 02.123.025S, 02.123.026, 02.123.026S, 02.123.027, 02.123.027S, 02.123.028, 02.123.028S, 02.123.029, 02.123.029S, 02.123.030, 02.123.030S, 02.123.031, 02.123.031S, 02.123.032, 02.123.032S, 02.123.033, 02.123.033S, 02.123.040, 02.123.040S, 02.123.041, 02.123.041S, 02.123.042, 02.123.042S, 02.123.043, and 02.123.043S. Lot numbers range form 6371761 through 6443098.

Orthopedic Devices

2

Yes

Worldwide distribution: USA and countries including: Bermuda, Korea, Italy, Japan, Georgia, Qatar and Turkey

3.5mm LCP Periarticular Proximal Humerus Plates || Indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly for patients with osteopenic bone

Part Number:. 00-0903-2634 and lot number 009U2

Orthopedic Devices

2

Yes

Worldwide Distribution - US including Michigan and the countries of Ireland and Australia

3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM || The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates provide ease of reduction and good rotational stability while maintaining bone stock. Cannulated instruments work over a guide wire for precise placement and safety. The subject device is a Bone Screw designed for use with this system.

Lot Number: 08060408

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS

Model Number 392-09-706, Lot Number 59602519

Orthopedic Devices

2

Yes

Worldwide Distribution including Venezuela.

3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. || The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

Lot Number: 08060410

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

Item Number 47-4840-010, 012, 014, 016, 018, 020, 022, 024, 026, 028, 030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-01

Orthopedic Devices

2

Yes

National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE

4.0 mm Cancellous Screw, Partially Threaded || Sterile || Zimmer

Part Number: 71240-14 Lot: 685904

Orthopedic Devices

2

Yes

Worldwide Distribution - US Distribution to the states of: KS, LA, TN, NJ, KY, CA, FL, OR, OK, AZ, WI, CO, IN, NH, AR, UT, and AL., and to the countries of : Spain, Japan, Belgium, and Saudi Arabia.

4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm || Alphatec Spine || Solutions for the Aging Spine || Trestle Luxe Anterior Cervical Plating System || REF 71240-14 || LOT XXXXXX || Alphatec Spine, Inc. || EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) || NON STERILE || Single Use Only

Model Number 14-521614B, lot number 375440.

Orthopedic Devices

2

Yes

Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

Item Number 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08

Orthopedic Devices

2

Yes

National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE

4.5 mm Malleolar Screw || Sterile || zimmer

Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.

4.5mm PLEO Osteotomy Guide. || OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.

Lot Numbers: 04GT81705C, 04GT82056B, 04HT82900A, 09FT33130, 10CT40239, 10JT46327, 11ET06848

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 04GT82057A, 04MT85468A, 04MT85468B, 05KT92810B, 06AT94674A, 07ET08636A, 07JT12782A, 08FT20859A, 08JT23728A, 08MT27100A, 09FT32616, 09HT34582, 09LT37632, 10BT39233, 10CT40112, 10DT41654, 10JT46328, 11CT04331, 11DT05508, 11FT07898, 11HT09584, 11JT10407, 11KT11408, 11LT12164, 11LT12306, 11MT13239

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 03JM10946B, 04BT78362A, 04BT78362B, 07AT05045A, 07HT11450A, 07JT12783A, 08BT17533A, 08FT20916A, 08MT26607A, 09FT32617, 09LT37633, 09MT38255, 10BT39234, 10CT40113, 10DT41655, 10HT45642, 10JT46329, 10MT01761, 10MT02101, 11DT05509, 11HT09585, 11JT10408, 11KT11409

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 03JM10950C, 03JM10951B, 04GT81708A, 04GT82059A, 04MT85470A, 06HT00329A, 08BT17534A, 08GT21566A, 08GT21566B, 08JT23729A, 09GT34300,  09LT37634, 10CT40114, 10DT41656, 10FT43816, 10JT46330, 10KT00286, 11ET06849, 11HT09586, 11JT10409, 11KT11410

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Numbers: 04CT79012A, 04GT81709B, 04GT81709C, 04MT85471A, 06KT02117A, 08BT17124A, 09FT33131, 10FT43817, 10JT46331, 11FT07897

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Number: 09KM13459A

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932948, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.

Lot Number 205091

Orthopedic Devices

2

Yes

Nationwide Distribution including Texas

5.0 mm Parafix Part Number 22-5011 is a suture anchor metal || Intended for rotator cuff repair.

Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012

Orthopedic Devices

2

Yes

Distributed in IL and IN.

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; || Catalog ID # 02.221.462S || Indicated for fixation of various long bones.

Lot number 16MM00441

Orthopedic Devices

2

Yes

US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA

smith&nephew; 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 || The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.

Lot Numbers: 09JM11593A, 09KM07719A

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey

6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932951, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 || Orthopedic surgical device.