Synthes, Inc.

Part 10847A

General and Plastic Surgery Devices

Unclassified

Yes

Distributed in the state of WI

Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Part Number 397.232, Lot Numbers  1698700 4688882 4868698 5129449 5345722 6009689 6235842 6407718 1702300 4688883 4916060 5129450 5356127 6021041 6241331 6407719 1715800 4772507 4916061 5129453 5382066 6023019 6258401 6446480 175220 4772508 4916062 5247085 5422622 6023020 6258402 6446481 1685602 4814278 4991953 5247087 5664372 6040195 6300954 6452871 1695100 4814280 4991962 5263641 5664373 6040196 6321761 6452872 1695101 4814281 4992455 5267067 5685461 6056610 6345256 6623687 1706600 4868678 5032047 5267068 5820702 6097962 6345257 6633304 1776300 4868685 5080386 5287150 5839165 6181398 6355110  1798900 4868691 5080387 5287152 5855648 6212655 6407717

General and Plastic Surgery Devices

1

No

Worldwide Distribution: US (nationwide) and internationally to Canada.

Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.

Sold Lot Numbers: 4520830 4519339 4528112 4527510 4527509 4528678 4529517 4532428 4542201 4547106 4547107 4548231 4552202 4552203 4562899 4566835 4572774 4572775 4578754 4581035 4593516 4738938 4768238 4805320 4805321 4805622 4805623 4814351 4869678 4871808 4880493 4880495 4888588 4915212 4915213 4935249 4935250 4964319 4964324 4973229 5021231 5021232 5021233 5036650 5036651 5056855 5056154 5056856 5079563 5079564 5079565 5079538 5090675 5090677 5105352 5144695 5144697 5144696 5161969 5161970 5191074 5196260 5229584 5229586 5229585 5229587 5253009 5256476 5256477 5262049 5267000 5276395 5278583 5283776 5283780 5353853 5360628 5367534 5367535 5370545 5388335 5370546 5388336 5765950 5775823; Manufacturing Lot Number A7LA49 A7LA48 A7LA51 A7LA50 A7LA50 A7LA51 A7LA51 A7LA47 A7MA03 A7MA05 A7MA05 A7MA05 A7MA06 A7MA06 A7MA09 A7MA10 A7MA11 A7MA11 A7MA13 A7MA14 A7MA18 A7NA08 A7NA08 A7NA25 A7NA25 A7NA25 A7NA25 A7NA25 A7NA40 A7NA41 A7NA43 A7NA43 A7NA43 A7NA43 A7NA51 A7NA52 A7NA51 A7OA09 A7OA09 A7OA09 A7OA21 A7OA21 A7OA21 A7OA24 A7OA24 A7OA30 A7OA29 A7OA33 A7OA29 A7OA35 A7OA35 A7OA36 A7OA38 A7OA38 A7OA41 A7OA50 A7OA50 A7OA50 A7OA51 A7OA51 A7PA07 A7PA08 A7OA50 A7OA51 A7PA08 A7PA07 A7PA20 A7PA21 A7PA21 A7PA21 A7PA23 A7PA23 A7PA24 A7PA25 A7PA25 A7PA39 A7PA40 A7PA41 A7PA41 A7PA42 A7PA41 A7PA42 A7PA43 A7PA47 A7PA47

Orthopedic Devices

1

No

Worldwide Distribution -- US and Canada.

2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) || Intended to be used for bending and/or cutting Mandible Locking Plates.

Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666

Orthopedic Devices

1

No

Nationwide Distribution

Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.

Part numbers:03.010.048 and 03.010.052 with  Lot Numbers:  4874015 4874021 4927262 4954481 4963192 4874016 4874022 4944750 4957586 4963193 4784017 4899564 4944751 4957587 4972003 4874018 4899565 4954478 4957588 4972004 4874019 4927260 4954479 4957589  4874020 4927261 4954480 4963190  4922533 4922975 4981158  4922970 4923015 4981159  4922971 4977241 4981160  4922972 4977242 4981162  4922973 4981156 5035905  4922974 4981157 5035906

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). || The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.