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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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OPTETRAK Comprehensive Knee System custom devices labeled as the following:
a. CUSTOM OPTETRAK A...
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2
|
10/04/2021
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Exactech, Inc.
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OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components.
NOTE: Informati...
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2
|
10/04/2021
|
Exactech, Inc.
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OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: ...
|
2
|
10/04/2021
|
Exactech, Inc.
|
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Produc...
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2
|
10/04/2021
|
Exactech, Inc.
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OPTETRAK Comprehensive Knee System, labeled as the following:
a. OPTETRAK All-polyethylene CR Ti...
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2
|
10/04/2021
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Exactech, Inc.
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Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Steri...
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2
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09/30/2021
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Corin Ltd
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Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile...
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2
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09/30/2021
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Corin Ltd
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Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a com...
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2
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09/30/2021
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Corin Ltd
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Univation X System knee implant devices as follows:
Catalog/Product:
NL482 UNIVATION F MENISCAL C...
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2
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09/22/2021
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Aesculap Implant Systems LLC
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Univation X System Tray Sysem knee implant devices as follows:
Tray Number/Set Name/Set Number
NM...
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2
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09/22/2021
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Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NO180Z AS UNIVATION XF FEMU...
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2
|
09/22/2021
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Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NO156Z AS UNIVATION XF TIBI...
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2
|
09/22/2021
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Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NL494 UNIVATION F MENISCAL C...
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2
|
09/22/2021
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Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NL488 UNIVATION F MENISCAL C...
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2
|
09/22/2021
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Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NL476 UNIVATION F MENISCAL C...
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2
|
09/22/2021
|
Aesculap Implant Systems LLC
|
Univation X System knee implant devices as follows:
Catalog/Product:
NL470 UNIVATION F MENISCAL C...
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2
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09/22/2021
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Aesculap Implant Systems LLC
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ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty
Part Number: 151...
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2
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08/25/2021
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DePuy Orthopaedics, Inc.
|
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3...
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2
|
08/09/2021
|
Medline Industries Inc
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Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irri...
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2
|
08/09/2021
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Medline Industries Inc
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DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Steri...
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2
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07/20/2021
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Encore Medical, LP
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DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Steri...
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2
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07/20/2021
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Encore Medical, LP
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LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral...
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2
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06/24/2021
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Smith & Nephew, Inc.
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DJO EMPOWR KNEE Femoral Sizer
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2
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04/30/2021
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Encore Medical, LP
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INFINITY_TRAY Custom Procedural Kit - Canada.
containing Infinity ACL Tibial Elbow and Tip Guides ...
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2
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04/27/2021
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ConMed Corporation
|
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides...
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2
|
04/27/2021
|
ConMed Corporation
|
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System,...
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2
|
04/09/2021
|
Howmedica Osteonics Corp.
|
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of th...
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2
|
03/29/2021
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DePuy Orthopaedics, Inc.
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ATTUNE® FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and p...
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2
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03/29/2021
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DePuy Orthopaedics, Inc.
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The ATTUNE® Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple component...
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2
|
03/29/2021
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DePuy Orthopaedics, Inc.
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Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/...
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2
|
03/08/2021
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Howmedica Osteonics Corp.
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Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noile...
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2
|
02/09/2021
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DePuy Orthopaedics, Inc.
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VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Prod...
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2
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01/29/2021
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Smith & Nephew, Inc.
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Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges.
1) Regard, PACEMAKER, I...
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2
|
12/28/2020
|
ROi CPS LLC
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Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee a...
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2
|
12/23/2020
|
Biomet, Inc.
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Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligam...
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2
|
12/21/2020
|
ConMed Corporation
|
Infinity ACL Tibial Tip Guide-
indicated for use in open and arthroscopic procedures for knee ligam...
|
2
|
12/21/2020
|
ConMed Corporation
|
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Pr...
|
2
|
12/17/2020
|
Biomet, Inc.
|
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
|
2
|
11/20/2020
|
Encore Medical, LP
|
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
|
2
|
11/20/2020
|
Encore Medical, LP
|
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 a...
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2
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11/19/2020
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Mako Surgical Corporation
|
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
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2
|
11/06/2020
|
Merete Medical GmbH
|
DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray ...
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2
|
10/07/2020
|
Encore Medical, LP
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PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable ...
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2
|
08/28/2020
|
Cardinal Health 200, LLC
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PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
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PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable ...
|
2
|
08/28/2020
|
Cardinal Health 200, LLC
|
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
Cat: TCR-121-1...
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2
|
08/22/2020
|
Conformis, Inc.
|
Tibial knee prosthesis
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2
|
08/08/2020
|
Smith & Nephew, Inc.
|
Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The syst...
|
2
|
07/10/2020
|
Cardinal Health 200, LLC
|
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage:
The systems are i...
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2
|
07/10/2020
|
Cardinal Health 200, LLC
|
Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box
|
2
|
06/30/2020
|
Mueller Sports Medicine, Inc
|
Knee Products:
183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM
183620 Vanguard Kne...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM
155326 Knees...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usa...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
141356 Regenerex Series-A Patella 3 Peg, 31 MM
141358 Regenerex Series-A Patella 3 ...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM
189720 Va...
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2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Le...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM;
184764 Knees...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Knee
Products:
183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM
EP-18360...
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2
|
05/28/2020
|
Biomet, Inc.
|
Knee Products:
189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM
189422 Vang...
|
2
|
05/28/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
|
2
|
04/03/2020
|
Biomet, Inc.
|
BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
|
2
|
04/03/2020
|
Biomet, Inc.
|
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LE...
|
2
|
04/01/2020
|
Conformis, Inc.
|
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT)...
|
2
|
04/01/2020
|
Conformis, Inc.
|
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.
NN081K
NN08...
|
2
|
03/13/2020
|
Aesculap Implant Systems LLC
|
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K
NN070...
|
2
|
03/13/2020
|
Aesculap Implant Systems LLC
|
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.
NN469K
NN47...
|
2
|
03/13/2020
|
Aesculap Implant Systems LLC
|
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos.
NN058Z
NN0...
|
2
|
03/13/2020
|
Aesculap Implant Systems LLC
|
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.
NR068K
NR...
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2
|
03/13/2020
|
Aesculap Implant Systems LLC
|
Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professiona...
|
2
|
03/05/2020
|
Gentell, Inc
|
Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professi...
|
2
|
03/05/2020
|
Gentell, Inc
|
Gentell Hydrogel Ag 4x4, model no. GEN-11420 - Product Usage: Under the care of a healthcare profess...
|
2
|
03/05/2020
|
Gentell, Inc
|
Gentell Hydrogel Ag 4x8, model no. GEN-11820 - Product Usage: Under the care of a healthcare profess...
|
2
|
03/05/2020
|
Gentell, Inc
|
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented to...
|
2
|
02/26/2020
|
Exactech, Inc.
|
TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of kne...
|
3
|
02/13/2020
|
Theralase Inc.
|
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic sur...
|
2
|
02/11/2020
|
Blue Ortho
|
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with...
|
2
|
01/24/2020
|
Enztec Limited
|
DeRoyal KNEE BRACE, WARRIOR RECOVERY:
1) REF KB9000-01
2) REF 11-450A-00
3) REF 1150UTPP
|
2
|
12/19/2019
|
DeRoyal Industries Inc
|
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable...
|
2
|
12/17/2019
|
Smith & Nephew, Inc.
|
iTotal CR Knee Replacement System
Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR ...
|
2
|
12/12/2019
|
Conformis, Inc.
|
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary rel...
|
3
|
12/05/2019
|
Theralase Inc.
|
TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
|
3
|
12/05/2019
|
Theralase Inc.
|
BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Leng...
|
2
|
12/02/2019
|
Brasseler USA I Lp
|
Various Knee Systems, Item Nos. 32855411838
32855411840
32855411842
32855411843
32855420307
328...
|
2
|
11/07/2019
|
Zimmer Biomet, Inc.
|
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100
0052200020...
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2
|
11/07/2019
|
Zimmer Biomet, Inc.
|
TxRx 15Ch Knee Coil 3T
QED part number:Q7000008
Siemens Model # 10185460
|
2
|
10/03/2019
|
Quality Electrodynamics LLC
|
TxRx 15CH Knee Coil 1.5T
QED part number:Q7000016
Siemens Model # 10185453
|
2
|
10/03/2019
|
Quality Electrodynamics LLC
|
TxRx 15CH Knee Coil 3T
QED part number: Q7000051
Siemens Model # 10606525
|
2
|
10/03/2019
|
Quality Electrodynamics LLC
|