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U.S. Department of Health and Human Services

Medical Device Recalls
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OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L ... 2 09/28/2022 Ossur Americas
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. 2 09/23/2022 Howmedica Osteonics Corp.
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. in... 2 07/15/2022 Aesculap Implant Systems LLC
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 2 06/09/2022 Encore Medical, LP
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack 2 05/06/2022 American Contract Systems, Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic ma... 2 04/29/2022 restor3d Inc.
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual ... 2 04/29/2022 restor3d Inc.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 2 04/08/2022 Conformis, Inc.
Total Knee Pack - Surgical Kit 2 04/04/2022 Stradis Medical, LLC dba Stradis Healthcare
NavitrackER Kit A: Knee, Model Number 20-8000-000-07, 2 03/03/2022 Orthosoft, Inc. dba Zimmer CAS
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty ... 2 02/09/2022 DePuy Orthopaedics, Inc.
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthropl... 2 02/09/2022 DePuy Orthopaedics, Inc.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in prep... 2 01/06/2022 Howmedica Osteonics Corp.
United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part, RHS, 25 mm Length, Cat... 2 10/14/2021 Uoc Usa Inc
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:15230700... 2 10/07/2021 DePuy Orthopaedics, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULI... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK A... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Informati... 2 10/04/2021 Exactech, Inc.
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... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Ti... 2 10/04/2021 Exactech, Inc.
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Steri... 2 09/30/2021 Corin Ltd
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile... 2 09/30/2021 Corin Ltd
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a com... 2 09/30/2021 Corin Ltd
Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMU... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBI... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL C... 2 09/22/2021 Aesculap Implant Systems LLC
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 151... 2 08/25/2021 DePuy Orthopaedics, Inc.
Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3... 2 08/09/2021 Medline Industries Inc
Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irri... 2 08/09/2021 Medline Industries Inc
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Steri... 2 07/20/2021 Encore Medical, LP
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Steri... 2 07/20/2021 Encore Medical, LP
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral... 2 06/24/2021 Smith & Nephew, Inc.
DJO EMPOWR KNEE Femoral Sizer 2 04/30/2021 Encore Medical, LP
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides ... 2 04/27/2021 ConMed Corporation
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides... 2 04/27/2021 ConMed Corporation
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System,... 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... 2 03/29/2021 DePuy Orthopaedics, Inc.
ATTUNE® FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and p... 2 03/29/2021 DePuy Orthopaedics, Inc.
The ATTUNE® Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple component... 2 03/29/2021 DePuy Orthopaedics, Inc.
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/... 2 03/08/2021 Howmedica Osteonics Corp.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noile... 2 02/09/2021 DePuy Orthopaedics, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Prod... 2 01/29/2021 Smith & Nephew, Inc.
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, I... 2 12/28/2020 ROi CPS LLC
Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee a... 2 12/23/2020 Biomet, Inc.
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligam... 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... 2 11/19/2020 Mako Surgical Corporation
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails 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 ... 2 10/07/2020 Encore Medical, LP
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable ... 2 08/28/2020 Cardinal Health 200, LLC
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
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... 2 08/22/2020 Conformis, Inc.
Tibial knee prosthesis 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... 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... 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... 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... 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

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