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Отзывов и мер
46
Класс I
4
наиболее опасные
Юрисдикций
5
Производителей
9
Что такое класс отзыва
Class I — обоснованная вероятность серьёзного вреда здоровью или смерти. Class II — вероятность временных или обратимых последствий. Классификацию присваивает регулятор, не мы.
Отзывы — 46
| Дата | Производитель | Изделие | Причина | Класс | Страна | Источник | У нас | Ссылка |
|---|---|---|---|---|---|---|---|---|
| 2026-08-19 | Waldemar Link GmbH & Co.… | Endo-Model, Replacement Set, Tibial Plateau… | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau.… | Class II | Германия | openFDA — device/enforcement | возможно | источник |
| 2026-08-12 | United Orthopedic Corp. | U2 Total Knee System Femoral valgus adaptor, left and right Mode… | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | Class II | Тайвань | openFDA — device/enforcement | возможно | источник |
| 2026-08-12 | United Orthopedic Corp. | U2 Total Knee System PSA Box Trial, L, #1-6 and PSA Box Trial, R… | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | Class II | Тайвань | openFDA — device/enforcement | возможно | источник |
| 2026-08-12 | United Orthopedic Corp. | USTAR II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Tria… | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | Class II | Тайвань | openFDA — device/enforcement | возможно | источник |
| 2026-08-12 | United Orthopedic Corp. | U2 Total Knee System Femoral valgus offset adaptor, 2mm, 4mm, 6m… | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | Class II | Тайвань | openFDA — device/enforcement | возможно | источник |
| 2026-08-11 | Waldemar Link GmbH & Co.… | Endo-Model, Replacement Set, Tibial Plateau… KRO | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau.… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-08-05 | United Orthopedic Corp. | U2 Total Knee System PSA Box Trial, L, #1-6 and PSA Box Trial, R… JWH | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | отзыв | Тайвань | openFDA — device/recall | возможно | источник |
| 2026-08-05 | United Orthopedic Corp. | USTAR II Knee System Hinge Box Trial, L, #1-6 and Hinge Box Tria… KRO | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem t… | отзыв | Тайвань | openFDA — device/recall | возможно | источник |
| 2026-07-29 | Medline Industries, LP | MEDLINE medical procedure convenience kit l… | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Inje… | Class I | США | openFDA — device/enforcement | — | источник |
| 2026-07-29 | Medline Industries, LP | MEDLINE medical procedure convenience kit l… | The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Inje… | Class I | США | openFDA — device/enforcement | — | источник |
| 2026-07-29 | Medline Industries, LP | MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ9… | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include… | Class I | США | openFDA — device/enforcement | — | источник |
| 2026-07-29 | Medline Industries, LP | MEDLINE convenience kits labeled as: 1) TOT… | Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include… | Class I | США | openFDA — device/enforcement | — | источник |
| 2026-07-22 | Medline Industries, LP | Medline Kits containing Zimmer Biomet mixin… | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present ris… | Class II | США | openFDA — device/enforcement | — | источник |
| 2026-07-22 | Medline Industries, LP | Medline Kits containing Zimmer Biomet mixin… | Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present ris… | Class II | США | openFDA — device/enforcement | — | источник |
| 2026-07-15 | Think Surgical, Inc. | TMINI Femur Tracking Array REF 109003 UDI-D… | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the… | Class II | США | openFDA — device/enforcement | — | источник |
| 2026-07-08 | Encore Medical, LP | EMPOWR 3D KNEE EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Cata… JWH | Due to packaging discrepancy with incorrect product size mixed up. | отзыв | США | openFDA — device/recall | — | источник |
| 2026-07-08 | Encore Medical, LP | EMPOWR 3D KNEE EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Cata… JWH | Due to packaging discrepancy with incorrect product size mixed up. | отзыв | США | openFDA — device/recall | — | источник |
| 2026-07-08 | Medline Industries, LP | Medline Convenience Kits: 1) SUTURE TRAY, M… | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice… | Class II | США | openFDA — device/enforcement | — | источник |
| 2026-07-08 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE Revision Hinge Knee H… | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Ирландия | openFDA — device/enforcement | — | источник |
| 2026-07-08 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE Revision Hinge Knee H… | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Ирландия | openFDA — device/enforcement | — | источник |
| 2026-07-01 | Zimmer, Inc. | Persona Revision Persona Revision¿ Trabecular Metal¿ Femoral… | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment pack… | Class II | США | openFDA — device/enforcement | возможно | источник |
| 2026-06-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE Revision Hinge Knee H… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-06-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE Revision Hinge Knee H… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-06-24 | Zimmer, Inc. | Persona Revision Persona Revision Trabecular Metal Femoral D… MBH | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment pack… | отзыв | США | openFDA — device/recall | возможно | источник |
| 2026-06-24 | Medline Industries, LP | Medline convenience kits: FEMORAL BLOCK TRA… | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation… | Class II | США | openFDA — device/enforcement | — | источник |
| 2026-06-17 | Howmedica Osteonics Corp. | TRI TS BASEPLATE SIZE 3. Part Number: 5521-… MBH | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Tri… | отзыв | США | openFDA — device/recall | — | источник |
| 2026-06-17 | Howmedica Osteonics Corp. | TRI TS BASEPLATE SIZE 4. Part Number: 5521-… MBH | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Tri… | отзыв | США | openFDA — device/recall | — | источник |
| 2026-06-10 | Kico Knee Innovation Comp… | Arvis Hip & Knee 3.0 Instrument Set, REF: I… | The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet… | Class II | Австралия | openFDA — device/enforcement | — | источник |
| 2026-06-10 | Kico Knee Innovation Comp… | Arvis Hip & Knee 2.0 Instrument Set, REF: I… | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the expose… | Class II | Австралия | openFDA — device/enforcement | — | источник |
| 2026-05-06 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Ирландия | openFDA — device/enforcement | — | источник |
| 2026-05-06 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Ирландия | openFDA — device/enforcement | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-04-29 | DEPUY (IRELAND) | Depuy Synthes, ATTUNE REVISION HINGE FEMORA… KRO | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | отзыв | Ирландия | openFDA — device/recall | — | источник |
| 2026-03-10 | Waldemar Link GmbH & Co.… | Endo-Model SL Connection Component incl. PE… KRO | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitud… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-03-10 | Waldemar Link GmbH & Co.… | Endo-Model Replacement Plateau; Item Number… KRO | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitud… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-03-10 | Waldemar Link GmbH & Co.… | Endo-Model SL Connection Component incl. PE… KRO | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitud… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-03-10 | Waldemar Link GmbH & Co.… | Endo-Model SL Connection Component incl. PE… KRO | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitud… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-03-10 | Waldemar Link GmbH & Co.… | Endo-Model Replacement Plateau; Item Number… KRO | The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitud… | отзыв | Германия | openFDA — device/recall | возможно | источник |
| 2026-02-24 | Encore Medical, LP | EMPOWR 3D KNEE EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catal… JWH | Knee and Humeral socket implants contain incorrect labeling. | отзыв | США | openFDA — device/recall | — | источник |
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