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)

product: FW103R, all Lots

Orthopedic Devices

1

No

Distributed US (nationwide) and to Canada.

S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.

All distributed lot numbers and serial numbers

Orthopedic Devices

1

No

Nationwide distribution, including the states of CA, CO, IL, LA, NV, OH, and TX .

S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.

4 degree - SJ768T-US and 9 degree SJ780T-US

Orthopedic Devices

1

No

US Nationwide Distribution - including the states of CO, OH, OK and TX.

Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) || Product Usage: || The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient

NQ083R

Orthopedic Devices

1

No

Within the US, product was distributed to PA and TN.

Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)

RT040R, all lot numbers

General and Plastic Surgery Devices

1

No

Nationwide Distribution.

UNITRAC Pneumatic Retraction Arm. || A support arm used to hold surgical instruments during surgical procedures.

Hi-Line XXS handpiece; Part Number - GB790R , Lot Number 4504385018 4504300008 4504328565 4504685847 4804685865

General and Plastic Surgery Devices

1

No

Worldwide Distribution - USA including TX, NY, PA, and TN. Internationally to Austria, Switzerland, Germany, Denmark, Spain, Finland, France, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Russian Federation, and Taiwan.

Aesculap Hi-Line XXS handpiece || Hi-Line XXS handpieces are used with the HiLAN¿ and microspeed motor systems to hold burrs which cut and shape bone.

Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17

Anesthesiology Devices

1

No

Nationwide Distribution.

CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn || Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural || Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural || Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, || PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous || Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; || Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). || Custom Epidural and Anesthesia Tray

All Lots

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Flexible Drill; || SJ723R; NON STERILE; || B Braun Aesculap; || Aesculap AG || These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

Product Information All lots affected  Product Description FC424R Valve XS Atrium Lift Ret. Blade50X35 FC425R Valve XS Atrium Lift Ret. Blade60X35 FC426R Valve XS Atrium Lift Ret. Blade70X35 FC428R Valve XS Atrium Lift Ret. Blade50X45 FC429R Valve XS Atrium Lift Ret. Blade60X45 FC430R Valve XS Atrium Lift Ret. Blade70X45 FC431R Valve XS Atrium Lift Ret. Blade25X20 FC432R Valve XS Atrium Lift Ret. Blade25X25 FC433R Valve XS Atrium Lift Ret. Blade40X25 FC434R Valve XS Atrium Lift Ret. Blade50X25 FC435R Valve XS Atrium Lift Ret. Blade25X40 FC436R Valve XS Atrium Lift Ret. Blade25X50 FC420R Valve XS Atrium Lift Ret. Blade Complete Set

General and Plastic Surgery Devices

1

No

US Distribution to state of: NY.

Valve XS Atrium Retractor || FC429R || 52154756 || The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.

all lots

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Flexible Bone Awl; || SJ607R; NON STERILE; || B Braun Aesculap; || Aesculap AG: || These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.

All Lots

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) and country of: Canada.

Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. || These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. || Tray catalog number is: Tray designated as ST0485-037.

Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).

General and Plastic Surgery Devices

1

No

US Distribution to: AL, IL, OK, MN, MA and WI.

Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) || Injection of anesthetics to provide regional anesthesia

Model numbers COARSE:  GP161R ; GP162R ; GP163R ; GP164R ; GP165R ; GP166R ; GP167R ; GP168R ; GP169R ; GP170R ;  Model numbers X-Course: GP173R ; GP174R ; GP175R ; GP176R ; GP177R ; GP328R ; GP329R ; GP330R ;

General and Plastic Surgery Devices

1

No

CA, IL, NY, PA, TN, TX

GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; || GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; || GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; || GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; || GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; || GP166R; ELAN 4 1-RING DIAMOND BURR+ COARSE D3,0; || GP167R; ELAN 4 1-RING DIAMOND BURR++ COARSE D3,0; || GP168R; ELAN 4 1-RING DIAMOND BURR COARSE D4,0; || GP169R; ELAN 4 1-RING DIAMOND BURR COARSE D5,0; || GP170R; ELAN 4 1-RING DIAMOND BURR COARSE D6,0; || GP173R; ELAN 4 1-RING DIAMOND BURR X-COARSE D3,0; || GP174R; ELAN 4 1-RING DIAMOND BURR X-COARSE D4,0; || GP175R; ELAN 4 1-RING DIAMOND BURR X-COARSE D5,0; || GP176R; ELAN 4 1-RING DIAMOND BURR X-COARSE D6,0; || GP177R; ELAN 4 1-RING DIAMOND BURR X-COARSE D7,0; || GP328R; ELAN 4 2-RING DIAMOND BURR X-COARSE D4.0; || GP329R; ELAN 4 2-RING DIAMOND BURR X-COARSE D5.0; || GP330R; ELAN 4 2-RING DIAMOND BURR X-COARSE D6.0;

Model numbers:  GP321R ; GP322R ; GP323R ; GP324R ; GP325R ;

General and Plastic Surgery Devices

1

No

CA, IL, NY, PA, TN, TX

GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; || GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; || GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; || GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; || GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0;

Model numbers:  GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;

General and Plastic Surgery Devices

1

No

CA, IL, NY, PA, TN, TX

GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; || GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; || GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; || GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; || GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; || GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5;

OM040R

Ear, Nose, and Throat Devices

1

No

nationwide

Doyen-Collin Mouth Gag 120MM/ General Instruments

EF401R

Gastroenterology-Urology Devices

1

No

nationwide

Strauss Penis Clamp 130MM/General Instruments

The product is located in the Vega Tibia preparation Tray (NS803) in the Vega Instrument Set (ST0468).

Orthopedic Devices

1

No

USA (nationwide)

NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) || The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint.

Product Catalog Number: 332215 332262 530024 530132 551714 551879 555184 555259 Lot Number 0061417406 0061421878 0061416371 0061420212 0061413247 0061416388 0061416389 0061414413

Anesthesiology Devices

2

No

Nationally

Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.

0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution.

Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. || Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198

General and Plastic Surgery Devices

2

No

Nationwide Distribution to GA, IL, and FL

Sterile IV Start Kits || 50 units/trays per case || Convenience kit for IV start procedures

Serial # 1229 1897 1898 1900 1909 1911 1929 1930 1932 1934 1938 1993 1997 1998 1999 2000 2029 2030 2031 2032 2037 2038 2039 2040 2041 2042 2045 2046 2047 2048 2049 2050 2051 2052 2168

General and Plastic Surgery Devices

2

No

USA (nationwide Distribution).

GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories

Item # FH620R

Neurological Devices

2

No

Product was distributed throughout the United States and Canada.

AESCULAP MINOP InVent 30 Trocar System, non-sterile || Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

0061523813. 0061536453.

General Hospital and Personal Use Devices

2

No

US Nationwide Distribution.

Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. || Local anesthesia of the skin prior to insertion of the regional anesthesia needle.