model no. ME020R

Orthopedic Devices

1

No

Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.

Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

Material Code MG096R  (1.1 CM) MG097R  (1.3 CM) MG227 (1.45CM) MG228  (1.6CM) MG229  (2.1 CM) MG230  (2.6CM)

Obstetrical and Gynecological Devices

2

No

Nationwide Distribution

Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life || The Gomco clamp is intended to be used for circumcision surgeries

All lots, Model Number: GP111R GP112R GP113R GP113TC GP114R GP115R GP116R GP117R GP118R GP119TC GP120R GP121R GP122R GP123R GP124R GP124TC GP125R GP126R GP126TC GP127R GP128R GP128TC GP129R GP129TC GP133R GP134R GP135R GP136R GP141R GP142R GP143R GP144R GP145R GP146R GP147R GP148R GP149R GP150R GP151R GP152R GP153R GP154R GP155R GP156R GP157R GP158R GP161R GP162R GP163R GP164R GP165R GP166R GP167R GP168R GP169R GP170R GP173R GP174R GP175R GP176R GP177R GP184R GP185R GP186R GP187R GP193R GP194R GP195R GP196R GP224R GP225R GP226R GP228R GP229R GP230R GP232R GP233R GP234R GP235R GP236R GP238R GP240R GP241R GP242R GP243R GP301R GP301TC GP302R GP302TC GP303R GP304R GP304TC GP305R GP306R GP306TC GP307R GP307TC GP308R GP308TC GP309R GP309TC GP311R GP312R GP313R GP314R GP315R GP316R GP317R GP321R GP322R GP323R GP324R GP325R GP328R GP329R GP330R GP335R GP336R GP337R GP338R GP339R GP350R GP355R GP356R GP357R GP358R GP374R GP375R GP376R GP378R GP379R GP380R GP382R GP384R GP385R GP386R GP388R GP389R GP391R GP392R GP393R GP395TC GP397R US792R US793R US794R US771R US772R US773R US774R US775R US776R US777R US783TC US785TC US787R US788TC US790TC US800R US801R US807R US852TC US853R US861R US825R US831R

Neurological Devices

2

No

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 || ELAN 4 1-RING ROSEN BURR+ D0.8 || ELAN 4 1-RING ROSEN BURR D1.0 || ELAN 4 1-RING ROSEN BURR TC D1.0 || ELAN 4 1-RING ROSENBURR+ D1.0 || ELAN 4 1-RING ROSEN BURR D1.4 || ELAN 4 1-RING ROSENBURR+ D1.4 || ELAN 4 1-RING ROSEN BURR D1.8 || ELAN 4 1-RING ROSEN BURR+ D1.8 || ELAN 4 1-RING ROSEN BURR TC D2.0 || ELAN 4 1-RING ROSEN BURR D2.3 || ELAN 4 1-RING ROSEN BURR+ D2.3 || ELAN 4 1-RING ROSEN BURR D2.7 || ELAN 4 1-RING ROSEN BURR+ D2.7 || ELAN 4 1-RING ROSEN BURR D3.0 || ELAN 4 1-RING ROSEN BURR TC D3.0 || ELAN 4 1-RING ROSEN BURR D3.5

All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R

Neurological Devices

2

No

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 || ELAN 4 1-RING TWIST DRILL D2.0 || ELAN 4 2-RING TWIST DRILL D1,0/4,0MM || ELAN 4 2-RING TWIST DRILL D1,1/4,0MM || ELAN 4 2-RING TWIST DRILL D1,2/4,0MM || ELAN 4 2-RING TWIST DRILL D1,5/4,0MM || ELAN 4 2-RING TWIST DRILL D1,5 || ELAN 4 2-RING TWIST DRILL D2,0 || ELAN 4 2-RING WIRE PASS DRILL D1.0 || ELAN 4 2-RING WIRE PASS DRILL D1.5 || ELAN 4 2-RING WIRE PASS DRILL D2.0 || ELAN 4 2-RING WIRE PASS DRILL D1.0 || ELAN 4 2-RING WIRE PASS DRILL D1.5 || ELAN 4 2-RING WIRE PASS DRILL D2.0

All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R

Neurological Devices

2

No

Distributed to 4 hospitals in the following states: NM, OH, TX, WV

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 || ELAN 4 1-RING NEURO CUTTER SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER D2.0 || ELAN 4 1-RING NEURO CUTTER D2.5 || ELAN 4 1-RING NEURO CUTTER D3.0 || ELAN 4 1-RING NEURO CUTTER TC D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 || ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG || ELAN 4 2-RING NEURO CUTTER SOFT D2,0 || ELAN 4 2-RING NEURO CUTTER SOFT D2,5 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER TC D3,0 || ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 || ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 || ELAN 4 2-RING DIAMOND DISC || ELAN 4 2-RING SIDE CUTTER TC D3,0 || SAW BLADE S sagittal 11/13/0,3 || SAW BLADE S sagittal 15/5/0,3 || SAW BLADE S sagittal 20/5/0,3 || SAW BLADE S sagittal 20/10/0,3 || SAW BLADE S sagittal 20/15/0,3 || SAW BLADE S sagittal 25/5/0,3 || SAW BLADE S sagittal 25/12/0,3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || ELAN 4 1-RING NEURO CUTTER D1.5+ || ELAN 4 1-RING NEURO CUTTER D2.0+ || ELAN 4 1-RING NEURO CUTTER D2.5+ || ELAN 4 1-RING NEURO CUTTER D3.0+ || ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 || ELAN 4 1-RING NEURO PRECISE D1.5 || ELAN 4 1-RING NEURO PRECISE D2.0 || ELAN 4 1-RING NEURO PRECISE D2.5 || ELAN 4 1-RING NEURO PRECISE D3.0 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5

JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202 JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202 JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202 JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202 JS489 S2 1/1-CONTAINER LID H202 JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202 JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202 JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202 JS789 S2 3/4 CONTAINER LID H202 JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202 JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202 JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202 JS389 S2 1/2 CONTAINER LID H202

General Hospital and Personal Use Devices

2

No

Nationally

JS Series SterilContainer S2 System

ELAN 4 Air System  ST0607 ELAN 4 Air Control Set  ST0608 ELAN 4 Air Neuro Crani Set  ST0609 ELAN 4 Air Spine Set  ST06411 ELAN 4 Air HD Spine Set  ST0614 ELAN 4 Air Micro Saw Set  ST0615 ELAN 4 Air Hand Control Set  ST0638 ELAN 4 Air Large Saw Set

Neurological Devices

2

No

Nationwide Distribution.

The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Lot numbers 301323A and 301393

General and Plastic Surgery Devices

Unclassified

No

The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.

D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

Lot numbers 60710907 and 60710908

Cardiovascular Devices

2

No

The product was shipped to two consignees that repack the product into their own kits.

7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.

Item number 474515. Lot number 0061014615 exp 6/30/2013

General Hospital and Personal Use Devices

2

No

Nationwide Distribution --- including states of CA, FL, NC, NJ, and TX.

Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.