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Crédits
Manufacturers
Ortho Development Corporation
Adresse du fabricant
Ortho Development Corporation, 12187 Business Park Drive, Draper UT 84020
Source
USFDA
5 Events
Rappel de Balanced Knee System
Rappel de Device Recall Hip Prostheses
Rappel de Device Recall Hip Prostheses
Rappel de Device Recall Hip Prostheses
Rappel de Device Recall Hip Prostheses
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5 dispositifs dans la base de données
Balanced Knee System
Modèle / numéro de série
Part # 252-0300, Lot # W007919.
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.
Description du dispositif
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Device Recall Hip Prostheses
Modèle / numéro de série
Catalog # 115-1015, Lot # W016134, W017080. Catalog # 115-1319, Lot # W016434.
Classification du dispositif
Orthopedic Devices
Distribution
TX and Japan
Description du dispositif
Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)
Device Recall Hip Prostheses
Modèle / numéro de série
Catalog # 114-0917, Lot # OD-18030-5, W003600, W003601, W003602. Catalog # 114-1017, Lot # OD-18563, OD-18563-1, OD-23190, OD-23191, OD-23221. Catalog # 114-1219, Lot # OD-23192, OD-23192-1, OD-23193, OD-23194. Catalog # 114-1421, Lot # OD-17306, OD-17412. Catalog # 114-1623, Lot # W0#003264, W003614.
Classification du dispositif
Orthopedic Devices
Distribution
TX and Japan
Description du dispositif
Hip Prosthesis as a component of Primaloc Cemented Hip System.
Device Recall Hip Prostheses
Modèle / numéro de série
Catalog # 111-0917, Lot # OD-22372. Catalog # 111-1015, Lot # OD-21589, OD-21589-1 Catalog # 111-1017, Lot # OD-23209. Catalog # 111-1019, Lot # OD-23235. Catalog # 111-1115, Lot # OD-22050. Catalog # 111-1117, Lot # OD-23205, OD-23205-1, OD-23298. Catalog # 111-1119, Lot # OD-22846, W002952, OD-23222. Catalog # 111-1217, Lot # OD-23207, OD-23208, OD-23299. Catalog # 111-1219, Lot # OD-22847, OD-20859-1, OD-23230, OD-22847-1. Catalog # 111-1221, Lot # OD-23254, OD-23249, Catalog # 111-1223, Lot # OD-18165, W002524. Catalog # 111-1319, Lot # OD-23231, OD-23231-1. Catalog # 111-1321, Lot # OD-23247. Catalog # 111-1421, Lot # OD-23250, OD-23255. Catalog # 111-1423, Lot # OD-23256. Catalog # 111-1425, Lot # OD-20837-1, W002683. Catalog # 111-1625, Lot # OD-21873, OD-19626-1, OD-22537.
Classification du dispositif
Orthopedic Devices
Distribution
TX and Japan
Description du dispositif
Hip Prosthesis as a component of Primaloc Cementless/Collarless Hip System
Device Recall Hip Prostheses
Modèle / numéro de série
Catalog # 112-0915, Lot # OD-18031, W003152, WO#003152. Catalog # 112-0917, Lot # OD-19103-1, OD-20567, W0#003109. Catalog # 112-1015, Lot # OD-19038, W0#003155. Catalog # 112-1017, Lot # OD-17403. Catalog # 112-1115, Lot # WO#003045. Catalog # 112-1117, Lot # OD-23210, OD-23211. Catalog # 112-1119, Lot # OD-23232. Catalog # 112-1217, Lot # OD-23206. Catalog # 112-1219, Lot # OD-23233. Catalog # 112-1221, Lot # OD-23252 Catalog # 112-1223, Lot # OD-17321, W003725, WO#003350. Catalog # 112-1319, Lot # OD-20572, OD-20867-1, OD-23234, OD-23234-1, OD-23246. Catalog # 112-1321, Lot # OD-23253. Catalog # 112-1421, Lot # OD-23248, OD-23248-1, OD-23251, OD-23251-1. Catalog # 112-1425, Lot # OD-21874. Catalog # 112-1623, Lot # OD-21147-1. Catalog # 112-1625, Lot # W0#003130, WO#003139.
Classification du dispositif
Orthopedic Devices
Distribution
TX and Japan
Description du dispositif
Hip Prosthesis as a component of Primaloc Cementless/Collared Hip System.
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Ortho Development Corporation
Adresse du fabricant
Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
Société-mère du fabricant (2017)
Ortho Development Corporation
Source
USFDA
Ortho Development Corporation
Adresse du fabricant
Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
Société-mère du fabricant (2017)
Ortho Development Corporation
Source
USFDA
Language
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