Part #487.975, Lot# A4JV281; 3959732; 3959733; 4038566; 4044600; 4095085; 4418691; 4479352; 4597089; 4767010; 4851967; 4851968; 5277361; 5346057; 5419963; 5433149; 5445352; 5445632; 5445638; 5785469; 5785471; 5828442; 5828447; 5847302; 5847357; 5883452; 6107608; 6107609; 6107614; 6107615; 6141641; 6141642; 6164420; 6164421; 6819614; 7489031; 7537257; 7865426; 7935481; A4JY058, mfg. date 14MAY1999 - 22APR2015, exp. date 06OCT2019-22APR2035

Dental Devices

2

Yes

Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.

TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 || The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

Item Number:00225248016, Lot Number Expiry Date Before: March 2027

Orthopedic Devices

2

Yes

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

Fem IM Nail 16mmdx48cm, Sterile, || Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Catalog No. SR60-300; Known Lot No. NHS160219.

Orthopedic Devices

2

Yes

Nationwide Distribution - US including CA and VA.

PALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.

Cardiovascular Devices

3

Yes

Worldwide Distribution

PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI || These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

Model L131

Cardiovascular Devices

3

Yes

AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

ESSENTIO MRI EL DR Pacemaker

Lot Number Unique Device Identifier (UDI) REAN0055 (01)00801741110771(17)170628(10)REAN0055 REAN0202 (01)00801741110771(17)170528(10)REAN0202 REAP0771 (01)00801741110771(17)170828(10)REAP0771 REAS1708 (01)00801741110771(17)171028(10)REAS1708 REAT0147 (01)00801741110771(17)171128(10)REAT0147 REAT1852 (01)00801741110771(17)171228(10)REAT1852 REAU1811 (01)00801741110771(17)171228(10)REAU1811 REAU2420 (01)00801741110771(17)171228(10)REAU2420 REAV2465 (01)00801741110771(17)180228(10)REAV2465 REAW1422 (01)00801741110771(17)180331(10)REAW1422 REAW1831 (01)00801741110771(17)180331(10)REAW1831 REAX1132 (01)00801741110771(17)180331(10)REAX1132 REAY1623 (01)00801741110771(17)180331(10)REAY1623 REAY2597 (01)00801741110771(17)180331(10)REAY2597 REBP0090 (01)00801741110771(17)180331(10)REBP0090 REBS1269 (01)00801741110771(17)181031(10)REBS1269 REBR1002 (01)00801741110771(17)181031(10)REBR1002 REBS1439 (01)00801741110771(17)181031(10)REBS1439 REBT1052 (01)00801741110771(17)181231(10)REBT1052 REBT2348 (01)00801741110771(17)181231(10)REBT2348 REBV0714 (01)00801741110771(17)190131(10)REBV0714 REBV1758 (01)00801741110771(17)190131(10)REBV1758 REBW1288 (01)00801741110771(17)190331(10)REBW1288 REBX1628 (01)00801741110771(17)190331(10)REBX1628 REBX2052 (01)00801741110771(17)190430(10)REBX2052

General Hospital and Personal Use Devices

2

Yes

Nationwide

POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300

Lots Y54D14 and Y54DY4.

Orthopedic Devices

3

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 2, 7.0 mm; Ref 1498-11-206.

Lots Y87G14, Y87G24 and Y87G34.

Orthopedic Devices

2

Yes

Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 1581-23-012.

Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213

General Hospital and Personal Use Devices

2

Yes

Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,

ChemoSite Implantable venous access sytem with printed Polyurethane Catheter and 9 French Introducer Kit || Catalog Number: 120045

Lot Numbers: N0A0278U N0A0597U N0A0603U N0C0403 N0C0405 N0C0439 N0E0113 N0E0423 N0E0426 N0F0426 N0F0446 N0G0266 N0G0279 N0G0557 N0H0123 N0L0372 N0L0400 N1A0928 N1A0930 N1C0009 N1C0048 N1E0182X N1E0932X N1G0241X N9E0801U N9E0802U N9E0803U N9H0598U N9M0251U

General and Plastic Surgery Devices

2

Yes

Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.

DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET6035 || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

00700504828 REV. SHELL LINER 0D 28X48 62192382 61924517 61979224 62102328 00701005028 REV. SHELL LINER 10D 28X50 61787378 61979209 62165315 62188095 00701005228 REV. SHELL LINER 10D 28X52 61979218 00701005428 REV. SHELL LINER 10D 28X54 61787382 62077039 00701005628 REV. SHELL LINER 10D 28X56 61799041 61976886 62165323 62188094 00701005828 REV. SHELL LINER 10D 28X58 61886620 62103434 00701006028 REV. SHELL LINER 10D 28X60 61979220 61979221 62077046 00701006228 REV. SHELL LINER 10D 28X62 61986244 62101503 62192380 00701006628 REV. SHELL LINE 10D 28X66 61787381 61979212 62042739 62042740 00702004828 REV. SHELL LINER 20D 28X48 61987076 00702005028 REV. SHELL LINER 20D 28X50 61987075 00702005228 REV. SHELL LINER 20D 28X52 62102429 00702005428 REV. SHELL LINER 20D 28X54 62103435 00702005628 REV. SHELL LINER 20D 28X56 61964049 62029515 62077034 62102329 00702006028 REV. SHELL LINER 20D 28X60 61787385 61853155 00702006228 REV. SHELL LINER 20D 28X62 61915568 61979214 62102867 00702006628 REV. SHELL LINER 20D 28X66 61787383 61787384 62102865

Orthopedic Devices

2

Yes

Nationwide and Foreign.

REV. SHELL LINER 0D 28X48 00700504828 || REV. SHELL LINER 10D 28X50 00701005028 || REV. SHELL LINER 10D 28X52 00701005228 || REV. SHELL LINER 10D 28X54 00701005428 || REV. SHELL LINER 10D 28X56 00701005628 || REV. SHELL LINER 10D 28X58 00701005828 || REV. SHELL LINER 10D 28X60 00701006028 || REV. SHELL LINER 10D 28X62 00701006228 || REV. SHELL LINE 10D 28X66 00701006628 || REV. SHELL LINER 20D 28X48 00702004828 || REV. SHELL LINER 20D 28X50 00702005028 || REV. SHELL LINER 20D 28X52 00702005228 || REV. SHELL LINER 20D 28X54 00702005428 || REV. SHELL LINER 20D 28X56 00702005628 || REV. SHELL LINER 20D 28X60 00702006028 || REV. SHELL LINER 20D 28X62 00702006228 || REV. SHELL LINER 20D 28X66 00702006628

CP Medical Product label is coded 8665P. Lot number J0629930-1 expiration 2011-09.  Private distributed label for Webster Veterinary is coded 07-836-4643(8665P). Lot number J0629930-1 expiration 2011-09.  Private distributed label for Butler is coded 032002. Lot number J0629930-1 expiration 2011-09.

General and Plastic Surgery Devices

2

Yes

Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa. Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution. Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.

Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. || Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament Polypropylene Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING 18' (45 cm) One Dozen Sterile Manufactured by: CP Medical Portland, OR USA' . Side of box has an adhesive sticker label which includes: 'Vet Use Only'. || Packet Label includes: '3/0 (2.0 metric) 8665 NFS-2 19mm 3/8 TAPER POLYPROPYLENE Blue Polypropylene Monofilament Synthetic Nonabsorbable Suture 18' (45 cm) STERILE EO Manufacturer: CP Medical Portland, OR USA' . || Product is also distributed under two private labels, Webster Veterinary and Butler. || Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile 07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2 18' (45 cm) 3/8 19mm'. || Webster Veterinary Packet Label includes: '3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene Nonabsorbable Sterile Suture Vet Use Only Distributed by: Webster Veterinary Supply, Inc. 07-836-4643(8665P) 26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'. || Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND Blue Monofilament Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45 cm) 3/8 19mm 01-B8665P-01 SUTUREVET'. || Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene Monofilament Synthetic Nonabsorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'.

Lot numbers M510790, M510800, M799990, M903250 and M089400.

Orthopedic Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.

Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116058, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc ¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.

Part 00595202017, all lots

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.

00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.

Lot Numbers: 12FTM0017A, 12FTM0017B, 12FTM0017C, 12FTM0019A. 12FTM0019B, 12FTM0019C, 12FTM0019D, 12FTM0020A, 12FTM0020B, 12FTM0020C, 12FTM0021A, 12FTM0021B, and 12FTM0021C

Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.

12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. || USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.

All lots

Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.

DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT || Catalog Number:283905000. || Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.

all SynchroMed II pumps

General Hospital and Personal Use Devices

3

Yes

worldwide

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the pump, catheter,r and catheter accessories || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of drugs or fluids:

Item #950502011

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) including AR,AZ,CA,CO,FL,GA,HI,IA,IL,IN,KY,LA,MA,MD,ME,MI,MN,MT,NC,NV,NY,OH,PA, TX,VA,WA,WI and Internationally to: AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CZECH REPUBLIC DENMARK EGYPT FRANCE GERMANY GREECE HOLLAND HUNGARY INDIA IRELAND ISRAEL ITALY JAPAN KOREA MALAYSIA NEW ZEALAND NORWAY P R CHINA PAKISTAN PANAMA POLAND PORTUGAL PUERTO RICO RUSSIA SAUDI ARABIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TURKEY UAE UK

SIGMA¿ LCS¿ HIGH PERFORMANCE" || MBT KEEL PUNCH CEMENTED || Size 2-3 || HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty

0700-026.

Orthopedic Devices

2

Yes

Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.

Reverse Shoulder Prosthesis (RSP) custom device component; 30mm RSP Glenoid Baseplate; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.

Lot# RL7075218, RL7064990, RL7064908, RL7054830, RL7044582, RL7034349, RL7034266, RL7024127, RL6123781, RL6113600, RL6103473, RL6103401, RL6103364, RL6083123, RL6083003, RL6072883, RL6062744, RL6052634, RL6052555, RL6042448, RL6032275, RL6022011, RL6011847, RL6011825, RL6011739, RL5121605, RL5121428, RL5111376, RL5090815, RF5072295, and RF5061643

Gastroenterology-Urology Devices

2

Yes

U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA || The product is used for long term hemodialysis vascular access.

Part Number 802-01-019  Lot 53944551

Orthopedic Devices

2

Yes

United States (FL and ID).

Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551

Lot Numbers: 9820027 9820415 11092859 11093048 11752551 11962126 11962127

Anesthesiology Devices

2

Yes

Worldwide Distribution - Only US distributed product is affected by recall

Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.

Lot 1PD0050401

Gastroenterology-Urology Devices

2

Yes

Nationwide distribution: Ohio only

Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. || Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.

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Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.

all serial numbers

Orthopedic Devices

2

Yes

nationwide

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF