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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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NexGen® Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw
Item Numb...
|
2
|
12/18/2018
|
Zimmer Biomet, Inc.
|
Vanguard Knee System -PS Open Box Femoral Right, 65 mm
Item Number:183108
|
2
|
11/21/2018
|
Zimmer Biomet, Inc.
|
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm
Item Number: 183126
|
2
|
11/21/2018
|
Zimmer Biomet, Inc.
|
Neodent® GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prostheti...
|
2
|
11/14/2018
|
Straumann Manufacturing, Inc.
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Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Prod...
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2
|
11/02/2018
|
Howmedica Osteonics Corp.
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Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System /...
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2
|
10/11/2018
|
Brainlab AG
|
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Model: TCR-111-1111
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2
|
10/02/2018
|
ConforMIS, Inc.
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JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 7402311...
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2
|
10/01/2018
|
Smith & Nephew, Inc.
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JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 7402111...
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2
|
10/01/2018
|
Smith & Nephew, Inc.
|
Journey BCS Knee CoCr Femoral Components, Catalog Numbers:
74021210, 74021211, 74021212, 74021213, ...
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2
|
10/01/2018
|
Smith & Nephew, Inc.
|
Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for ...
|
2
|
09/26/2018
|
Zimmer Biomet, Inc.
|
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224
I...
|
2
|
09/25/2018
|
Zimmer Biomet, Inc.
|
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221
...
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2
|
09/25/2018
|
Zimmer Biomet, Inc.
|
Optetrak Logic CC Stem Extension, 22mm x 160mm
The OPTETRAK Logic CC Total Knee System is indicat...
|
2
|
09/20/2018
|
Exactech, Inc.
|
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933
Product Usage:...
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2
|
09/15/2018
|
Mako Surgical Corporation
|
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component.
The Founda...
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2
|
08/31/2018
|
Encore Medical, Lp
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P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
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2
|
08/29/2018
|
DePuy Orthopaedics, Inc.
|
Stryker Mako Vizadisc Knee Procedure Tracking Kit
|
2
|
08/24/2018
|
Mako Surgical Corporation
|
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthe...
|
2
|
08/22/2018
|
Smith & Nephew, Inc.
|
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35
Product Usage:
...
|
2
|
08/18/2018
|
Zimmer Biomet, Inc.
|
Rio System Irrigation Clip - Catalog # 111690
Product Usage:
The RESTORIS Partial Knee Applicati...
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2
|
08/14/2018
|
Mako Surgical Corporation
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Think Surgical Cutter, Flat, ®6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Pa...
|
2
|
08/06/2018
|
Think Surgical, Inc.
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Apollo XT Suture Anchor, 5.5 x 15
Product Usage:
Apollo XT Suture Anchors are intended for: Shou...
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2
|
07/13/2018
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Valeris Medical, LLC
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Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301
Product Usage:
Hyalomatrix is a bi-...
|
2
|
07/11/2018
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Anika Therapeutics, Inc.
|
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642
...
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2
|
06/04/2018
|
Zimmer Biomet, Inc.
|
Vanguard Knee System PS Tibial Bearing, Part Number 183621
Intended for use in knee joint replac...
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2
|
06/01/2018
|
Zimmer Biomet, Inc.
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Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 14...
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2
|
06/01/2018
|
Zimmer Biomet, Inc.
|
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014
The GENESIS ...
|
2
|
05/21/2018
|
Smith & Nephew, Inc.
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Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the...
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2
|
05/08/2018
|
Zimmer Biomet, Inc.
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Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the...
|
2
|
05/08/2018
|
Zimmer Biomet, Inc.
|
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the...
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2
|
05/08/2018
|
Zimmer Biomet, Inc.
|
Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the...
|
2
|
05/08/2018
|
Zimmer Biomet, Inc.
|
Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the...
|
2
|
05/08/2018
|
Zimmer Biomet, Inc.
|
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the...
|
2
|
05/08/2018
|
Zimmer Biomet, Inc.
|
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements...
|
2
|
05/04/2018
|
Mako Surgical Corporation
|
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
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2
|
04/30/2018
|
DePuy Orthopaedics, Inc.
|
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
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2
|
04/30/2018
|
DePuy Orthopaedics, Inc.
|
Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600
...
|
2
|
04/25/2018
|
Zimmer Biomet, Inc.
|
Knee Prosthesis, Sterile, Single-Use devices
Product Usage:
The knee system devices are intended...
|
2
|
04/24/2018
|
Howmedica Osteonics Corp.
|
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601
The knee system devices are s...
|
2
|
04/20/2018
|
Howmedica Osteonics Corp.
|
Persona Partial Knee Spacer Blocks
To assist in partial knee arthroplasty surgery
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2
|
03/28/2018
|
Zimmer Biomet, Inc.
|
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm ...
|
2
|
03/28/2018
|
Zimmer Biomet, Inc.
|
PERSONA® THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe ...
|
2
|
03/27/2018
|
Zimmer Biomet, Inc.
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smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERI...
|
2
|
03/19/2018
|
Smith & Nephew, Inc.
|
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L
The Apex Knee System is int...
|
2
|
03/19/2018
|
OMNIlife science Inc.
|
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3,
11mm Thick Catalogue number 2303-3032...
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2
|
03/19/2018
|
United Orthopedic Corporation
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U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016
The U2 Total K...
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2
|
03/19/2018
|
United Orthopedic Corporation
|
Vanguard CR Porous Femoral 62.5mm (Left Femur)
For use in total knee arthroplasty
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS FEM COMP SZ B-L
LPS FEM COMP SZ B-R
LPS FEM COMP SZ C-L
LPS FEM COMP SZ C-R
LPS FEM COMP SZ ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS OPTION FEMORAL C-L
LPS OPTION FEMORAL C-R
LPS OPTION FEMORAL D-L
LPS OPTION FEMORAL D-R
LPS ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS FEM IMPLANT SZ H-R
This device is indicated for patients with severe knee pain and disability
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
NP FEM LT SZ0 NATURAL-KNE
NP FEM RT SZ0 NATURAL-KNE
NP FEM LT SZ2 NATURAL-KNE
NP FEM RT SZ2 NATUR...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX POR HATCP FEM C-L
CR-FLEX POR HATCP FEM C-R
CR-FLEX POR HATCP FEM D-L
CR-FLEX POR HATCP F...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLX POR HATCP FEM C-L MINUS
CR-FLX POR HATCP FEM C-R MINUS
CR-FLX POR HATCP FEM D-L MINUS
CR-F...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT®
N-K FLX GSM POR FEM SZ 2 RT
N-K FL...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR POR FEM HATCP
SIZE E/L
SIZE F/L
Knee Prosthesis
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS®...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX GSF PRECOAT SZ C-L®
CR-FLEX GSF PRECOAT SZ C-R®
CR-FLEX GSF PRECOAT SZ D-L®
CR-FLEX GSF P...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX GSF PCT SZ C-R MINUS®
CR-FLEX GSF PCT SZ D-L MINUS®
CR-FLEX GSF PCT SZ D-R MINUS®
CR-FLEX...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT®
" These devices are indicated for patients with...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
FEM PRC LT M/RT L SML
FEM PRC RT M/LT L SML
FEM PRC LT M/RT L SML+
FEM ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
ZUK PRC FEM SZB RMED/LLAT®
ZUK PRC FEM SZC LMED/RLAT®
ZUK PRC FEM SZC RMED/LLAT®
NGU PRC FEM SZD ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
PRCT MIS CR MOB PLT SZ 4 L®
PRCT MIS CR MOB PLT SZ 5 L®
PRCT MIS CR MOB PLT SZ 6 L®
PRCT MIS CR M...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX PCT FEM B-R
CR-FLEX PCT FEM C-L
CR-FLEX PCT FEM C-R
CR-FLEX PCT FEM D-L
CR-FLEX PCT FEM ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX PCT FEM C-R MINUS
CR-FLEX PCT FEM D-L MINUS
CR-FLEX PCT FEM D-R MINUS
CR-FLEX PCT FEM E-L...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX POR FEM F-L
CR-FLEX POR FEM F-R MINUS
CR-FLEX POR FEM G-L
This device is indicated for ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX OPT FEM C-L
CR-FLEX OPT FEM C-R
CR-FLEX OPT FEM D-L
CR-FLEX OPT FEM D-R
CR-FLEX OPT FEM ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR-FLEX OPT FEM C-R MINUS
CR-FLEX OPT FEM D-L MINUS
CR-FLEX OPT FEM D-R MINUS
CR-FLEX OPT FEM E-L...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT
This device is indicated for patients with severe knee ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS-FLEX PRECOAT FEMORAL B-R
LPS-FLEX PRECOAT FEMORAL C-L
LPS-FLEX PRECOAT FEMORAL C-R
LPS-FLEX P...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS-FLEX OPTION FEMORAL C-L
LPS-FLEX OPTION FEMORAL C-L
LPS-FLEX OPTION FEMORAL C-R
LPS-FLEX OPTI...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR OPTION FEM COMP SIZE C/L
CR OPTION FEM COMP SIZE C/R
CR OPTION FEM COMP SIZE D/L
CR OPTION FEM...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
CR PRECOAT FEM COMP SIZE BMR
CR PRECOAT FEM COMP SIZE C/R
CR PRECOAT FEM COMP SIZE D/R
CR PRECOAT...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS PRECOAT FEM SIZE D-RT
LPS PRECOAT FEM SIZE E-RT
LPS POROUS FEM SIZE F-RT
This device is ind...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS PRECOAT SRF HDN FEM SZ D-L
LPS PRECOAT SRF HDN FEM SZ D-R
LPS PRECOAT SRF HDN FEM SZ E-L
LPS ...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LPS POROUS FEM IMPLANT SZ G-L
LPS PRECOAT FEM IMPLANT SZ G-L
This device is indicated for patien...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
LCCK FEM IMPLANT SZ C-L
LCCK FEM IMPLANT SZ C-R
LCCK FEM IMPLANT SZ D-R
LCCK FEM IMPLANT SZ E-L
...
|
2
|
03/14/2018
|
Zimmer Biomet, Inc.
|
O-arm® O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000
The O-arm O2 Ima...
|
2
|
03/08/2018
|
Medtronic Navigation, Inc.-Littleton
|
OTTO BOCK Kenevo knee joints Model 3C60
|
2
|
03/01/2018
|
Otto Bock Healthcare Product
|
OTTO BOCK Kenevo knee joints Model 3C60=ST
|
2
|
03/01/2018
|
Otto Bock Healthcare Product
|
AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
|
2
|
02/28/2018
|
Avid Medical, Inc.
|
The 2nd Assist Knee Positioner
|
2
|
02/28/2018
|
Zimmer Biomet, Inc.
|
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows:
a. VERSYS 6 INCH BEADED ...
|
2
|
02/26/2018
|
Zimmer Biomet, Inc.
|
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows:
a. Size B-LT (Item No. 00585001201)...
|
2
|
02/26/2018
|
Zimmer Biomet, Inc.
|
NexGen LPS Femoral Component, Left and Right, Size G
Replaces the femoral condyle of the knee joi...
|
2
|
02/21/2018
|
ZIMMER ORTHOPEDIC MFG LTD
|
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540
Pr...
|
2
|
02/21/2018
|
Zimmer Biomet, Inc.
|
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442
Product U...
|
2
|
02/21/2018
|
Zimmer Biomet, Inc.
|
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The fir...
|
2
|
02/16/2018
|
Oculus Optikgeraete GMBH
|
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.
Product Usage:
For...
|
2
|
02/15/2018
|
Zimmer Biomet, Inc.
|
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802.
Product Usage:
For ...
|
2
|
02/15/2018
|
Zimmer Biomet, Inc.
|
Persona Partial Knee System
Product Usage:
The Persona Partial Knee System instruments are used ...
|
2
|
02/14/2018
|
Zimmer Biomet, Inc.
|
Synvisc-One ® (hylan G-F 20), 6mL delivered from a 10mL syringe
Product Usage:
A elastoviscous h...
|
2
|
02/14/2018
|
Sanofi Genzyme
|
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- an...
|
2
|
02/13/2018
|
ConforMIS, Inc.
|
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST046...
|
2
|
02/12/2018
|
Aesculap Implant Systems LLC
|
Persona Partial Knee System, Size 8, Finishing Guide
|
2
|
01/14/2018
|
Zimmer Biomet, Inc.
|
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Contai...
|
2
|
01/12/2018
|
DeRoyal Industries Inc
|
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in ortho...
|
2
|
01/10/2018
|
Encore Medical, Lp
|
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthope...
|
2
|
01/10/2018
|
Encore Medical, Lp
|
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE,
REF 801-05-042, NON STERILE, Qty 1 For use in orthope...
|
2
|
01/10/2018
|
Encore Medical, Lp
|
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthop...
|
2
|
01/10/2018
|
Encore Medical, Lp
|