Z-2331-2021Class II

AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part #...

Name: Z-2331-2021 AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part #...
Creator: Encore Medical, LP
Published: 2021-06-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2021-06-28 / Open, Classified

FDA source

Encore Medical, LP began a recall of 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 #... on 2021-06-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2331-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-28
Posted: 2021-08-23
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
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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.
FDA 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 [email protected] and [email protected] by July 31, 2021.
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2331-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2331-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-23

Product code KWS

K162024Class IIAltiVate Anatomic Shoulder SystemEncore Medical L.P. / cleared 2016-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)