FDA Medical Device Recalls (openFDA)
Encore Medical, LP: 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
- Recall number
- Z-2331-2021
- Recalling firm
- Encore Medical, LP
- 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
- Status
- Open, Classified
- Initiated
- 2021-06-28
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process change control
- Action
- On June 28, 2021, Encore Medical (DJO) issued a "Urgent Medical Device Recall" Notification to affected consignees, via E-Mail. In addition to informing consignees about the recall devices, the firm asked consignees to take the following actions by July 19, 2021: 1. Review your stock for the affected products and lot numbers and quarantine the items until returned. 2. Communicate the affected parts, lots, and quantities that you have in stock to your sales Agent and arrange to return all affected, unused product to your sales Agent. 3. Report any adverse events related to this issue to DJO Customer Service (1-800-456-8696). Please also note that Adverse reactions or quality problems experienced with the use of this product MAY be reported to the FDAs MedWatch Adverse Event reporting program either online, by regular mail or by fax. 4. Complete the Medical Device Recall acknowledge and receipt form (including all information in the yellow-highlighted cells) with all available information and return by e-mail to julie.baker@djoglobal.com and david.evans1@djoglobal.com by July 31, 2021.
- Quantity
- not on file
- Distribution
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K162024"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28