Smith & Nephew, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 18 510(k) filings: 2 Recalls: 27

Known Identifiers & Locations

FEI Numbers 1020279, 1219602, 1643264, 3002788818, 3002807893, 3003604053, 3005551626, 3006760724, 3007282753, 3008744062, 3010034780, 3010813691, 3012130335, 3012358417, 3013881076, 3016090213, 3022142628, 3026368553, 3038503932
Owner Operator Numbers 1020279, 9002406
Locations Covered AARAU Aargau, CH; ANDOVER, MA, US; Austin, TX, US; Cordova, TN, US; Coyol Alajuela, CR; Kfar Saba Central, IL; Lawrenceville, GA, US; MANSFIELD, MA, US; MEMPHIS, TN, US; Maple Plain, MN, US; Memphis, TN, US; OKLAHOMA CITY, OK, US; Penang Pulau Pinang, MY; Pittsburgh, PA, US

Registered Establishments (18)

Registration # Establishment Name Location Establishment Type(s) Action
1020279 SMITH & NEPHEW, INC. MEMPHIS, TN, US Manufacture Medical Device View Details
1219602 SMITH & NEPHEW INC. MANSFIELD, MA, US Manufacture Medical Device View Details
1643264 SMITH & NEPHEW INC. OKLAHOMA CITY, OK, US Manufacture Medical Device View Details
3003604053 SMITH & NEPHEW INC. ANDOVER, MA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3005551626 SMITH & NEPHEW, INC. Memphis, TN, US Manufacture Medical Device View Details
3006524618 ArthroCare Corporation Austin, TX, US Develop Specifications But Do Not Manufacture At This Facility View Details
3007366790 Smith & Nephew, Inc. Memphis, TN, US Manufacture Medical Device View Details
3008744062 Smith & Nephew, Inc. Cordova, TN, US Develop Specifications But Do Not Manufacture At This Facility View Details
3010034780 Smith & Nephew, Inc. Lawrenceville, GA, US Repack or Relabel Medical Device View Details
3012130335 Tusker Medical Inc. Austin, TX, US Develop Specifications But Do Not Manufacture At This Facility View Details
3012358417 Arthrocare Corporation Coyol Alajuela, CR Manufacture Medical Device View Details
3013881076 CARTIHEAL LTD. Kfar Saba Central, IL Repack or Relabel Medical Device,Manufacture Medical Device View Details
3014207283 Ascension Orthopedics, Inc. Austin, TX, US Manufacture Medical Device View Details
3016090213 Blue Belt Technologies, Inc. Pittsburgh, PA, US Manufacture Medical Device View Details
3022142628 Smith and Nephew Operations Sdn. Bhd Penang Pulau Pinang, MY Manufacture Medical Device View Details
3026368553 INTEGRITY ORTHOPAEDICS, INC. Maple Plain, MN, US Manufacture Medical Device View Details
3038503932 Smith & Nephew, Inc. Memphis, TN, US Manufacture Medical Device View Details
9613369 SMITH & NEPHEW ORTHOPAEDICS AG AARAU Aargau, CH Manufacture Medical Device View Details

510(k) Premarket Notifications (2)

Submission # Device Name Decision Date Decision Description Action
K072322 ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18 Substantially Equivalent View Details
K223112 MAVERICK Mini External Fixation System 2022-12-08 Substantially Equivalent View Details

FDA Recall History (27)

Recall # Product Description Initiation Date Status Action
Z-0001-2019 Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229 Reason: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries. 2018-06-13 Open, Classified View Details
Z-0002-2019 JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149 Reason: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries. 2018-06-13 Open, Classified View Details
Z-0003-2019 JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326 Reason: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates reported in those registries. 2018-06-13 Open, Classified View Details
Z-0009-2007 Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. Reason: Tibial punches were not manufactured to specification and could break at the tip during use. 2006-08-29 Terminated View Details
Z-0010-2007 Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 Reason: Tibial punches were not manufactured to specification and could break at the tip during use. 2006-08-29 Terminated View Details
Z-0011-2007 Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 Reason: Tibial punches were not manufactured to specification and could break at the tip during use. 2006-08-29 Terminated View Details
Z-0016-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0017-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0018-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0019-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0020-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0021-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0022-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0023-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0024-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0025-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0026-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0027-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0028-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0029-2008 Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0030-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0031-2008 Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0032-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0033-2008 Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component. Reason: The carton label may not reflect the correct size of the acetabular cup. 2007-07-12 Terminated View Details
Z-0039-2015 RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. 2014-07-18 Terminated View Details
Z-0040-2015 RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. 2014-07-18 Terminated View Details
Z-0041-2015 RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT). Reason: RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. 2014-07-18 Terminated View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.