Encore Medical, LP: Medical Device Recall in 2021 - (Recall #: Z-2331-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 28, 2021

Date Posted: September 1, 2021

Recall Number: Z-2331-2021

Event ID: 88223

Reason for Recall:

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

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

Distribution Pattern:

US: 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,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A

Voluntary or Mandated:

Voluntary: Firm initiated