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Devices
Device Recall Stryker Recon, Radial Implant, Standard Stem
모델명 / 제조번호(시리얼번호)
Part Number: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566, 18567, 18568, 18697, 18837, 22297901, 22297902, 22848901, 19099-S2, 19101-S2, 19684-S2, 19685-S2, 19716-S2, 19769-S2, 19803-S2, 19846-S2, 19918-S2, 19919-S2 and 19982-S2; Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295, 18753, 18839, 22098402, 22298001, 22298002, 22614201, 22614202, 22849101, 23068301, 19664-S2, 19718-S2, 19719-S2, 19770-S2, 19771-S2, 19772-S2, 19805-S2, 19847-S2, 19848-S2, 19849-S2, 19850-S2 and 19921-S2; Part Number: RCN-S3 (#3 Bipolar Stem Implant - Sterile packed) - Lot #'s 18296, 18754, 22298101, 22298102, 22614401, 22614402, 22849301, 23068501, 23068502, 23479701, 19665-S2, 19720-S2, 19721-S2, 19722-S2, 19774-S2, 19775-S2, 19776-S2, 19806-S2, 19852-S2, 19853-S2 and R237901; Part Number: RCN-S4 (#4 Bipolar Stem Implant - Sterile packed) - Lot #'s 18885, 18886, 22298201, 22298202, 22614501, 22614502, 22849501, 23068601, 23479901, 19666-S2, 19724-S2, 19725-S2, 19777-S2, 19808-S2, 19855-S2, 19856-S2, 19922-S2, 19988-S2 and R23479901 Part Number: RHA-S1 (Radial Stem Implant #1 - Sterile packed) - Lot #'s 18374, 18387, 18500, 18574, 18705, 18706, 18845, 18846, 18847, 22613001, 22850001, 23069001, 19111-S2, 19112-S2, 19726-S2, 19778-S2 and 19857-S2; Part Number: RHA-S2 (Radial Stem Implant #2 - Sterile packed) - Lot #'s 22098802, 22279401, 22279402, 22613201, 22850201, 23069201, 23493402, 109667-S2, 19780-S2 19781-S2, 19810-S2, 19859-S2, 19860-S2, 19861-S2, 19923-S2 and R23493402; Part Number: RHA-S3 (Radial Stem Implant #3 - Sterile packed) - Lot #'s 18855, 22098902, 22279501, 22279502, 22613401, 22613402, 22850401, 23069401, 23226201, 23490201, 19687-S2, 19727-S2, 19728-S2, 19729-S2, 19783-S2, 19811-S2, 19812-S2, 19862-S2, 19863-S2, 19924-S2, 19925-S2 and R23490201; Part Number: RHA-S4 (Radial Stem Implant #4 - Sterile packed) - Lot #'s 18378, 22279601, 22613601, 22613602, 22850601, 23069501, 23226301, 23491501, 19668-S2, 19784-S2, 19814-S2, 19864-S2, 19926-S2, 19927-S2 and R23491501; Part Number: WA/C-L (Wrist Carpal Implant Large) - Lot #'s 23689901, 23946601, 23946602, 23946603, 24056601 and 19064-S2; Part Number: WA/C-M (Wrist Carpal Implant Medium) - Lot #'s 22296901, 22296902, 22595501, 22595502, 22758401, 22758402, 23041201, 23216201, 23689801, 23689802, 23689803, 23946801, 23946802, 23946803, 24056701, 24056702 and 24056703; Part Number: WA/C-S (Wrist Carpal Implant Small) - Lot #'s 22297001, 22297002, 22431101, 22595601, 225965602, 22758501, 22758502, 23041301, 23689701, 23689702, 23689703, 23946701, 23946702, 23946703, 24056801, 24056802 and 24056803; Part Number: WA/R-LL (Wrist Left Radial Implant Large) - Lot #'s 18872, 23946901, 23946902, 23946903, 24056901, 19061-S2, 19605-S2, 19828-S2, 19829-S2, 19955-S2, R19605-S2, R19828-S2 and R19829-S2; Part Number: WA/R-LM (Wrist Left Radial Implant Medium) - Lot #'s 22595701, 22758601, 22758602, 23041401, 23690401, 23690401, 23690402, 23690403, 24057001, 19062-S2, R23690401, R23690402 and R23690403; Part Number: WA/R-LS (Wrist Left Radial Implant Small) - Lot #'s 22758701, 22758702, 23041501, 23216301, 23690501, 23690502, 24057101, 24057102, R23690501 and R23690502; Part Number: WA/R-LXS (Distal Radial Comp X-Small, Left, Sterile) - Lot #'s 18794, 18873, 22758801, 22758802 and 23041601; Part Number: WA/R-RL (Wrist Right Radial Implant Large) - Lot #'s 18795, 23690001, 23690002, 23690003, 24057201, R23690001, R23690002 and R23690003; Part Number: WA/R-RM (Wrist Right Radial Implant Medium) - Lot #'s 15892, 22297101, 22595801, 22758901, 22758902, 23041701, 23261401, 23690101, 23690102, 23690103, 23947101, 23947102, 24057301, R23690101 and R23690102; Part Number: WA/R-Rs (Wrist Right Radial Implant Small) - Lot #'s 22297201, 22595901, 22595901, 22595902, 22759001, 22759002, 23041801, 23261501, 23690201, 23690202, 23690203, 23947001, 23947002, 23947003, 23947004, 24057401, 19073-S2, R23690201 and R23690202; Part Number: WA/R-RXS (Distal Radial Comp X-Small, Right, Sterile) - Lot #'s 18796, 18874, 22596001, 22759101, 22759102, 23041901, 23690301, 23690302, 23690303, 23947201, 24057501, R23690301, R23690302 and R23690303.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution.
제품 설명
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Device Recall Stryker Recon, Radial Implant, Standard Stem 의 리콜
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제조사
Stryker Howmedica Osteonics Corp.
제조사 주소
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
제조사 모회사 (2017)
Stryker
Source
USFDA
Language
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