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Devices
Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0600-273, 0600-283, and 0600-293.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; RSP/Foundation Socket Spacer; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
1 Event
Device Recall Reverse Shoulder Prosthesis device components 의 리콜
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제조사
Encore Medical, Lp
제조사 주소
Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
Source
USFDA
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Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0700-031.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0700-026.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; 30mm RSP Glenoid Baseplate; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0600-296.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; 32mm Neutral Socket; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0700-025.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; 32mm RSP Glenoid Baseplate; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
Device Recall Reverse Shoulder Prosthesis device components
모델명 / 제조번호(시리얼번호)
0700-033.
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
제품 설명
Reverse Shoulder Prosthesis (RSP) custom device component; 36mm RSP Glenoid Head; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Manufacturer
Encore Medical, Lp
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