medical Class II Updated 2021-09-01

Encore Medical, LP recalls AltiVate Anatomic Shoulder System for the following Part Num

Recalled Product

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000

Hazard / Issue

Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, MT, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV
Lot/Code Info: Part number/ Lot number: 1. 520-08-000 / 85OU1108; 85OU1110; 85OU1111, 2. 520-10-000 / 851U1256; 851U1257; 851U1258; 851U1259, 3. 520-12-000 / 852U1402; 852U1393; 852U1404; 852U1395; 852U1398A, 852U1405; 852U1397; 852U1391; 852U1400; 852U1398; 852U1407; 852U1396; 852U1406, 4. 520-14-000 / 853U1234; 853U1240; 853U1241A; 853U1238; 853U1239; 853U1237; 853U1241, 5. 520-16-000 / 854U1076; 854U1077
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