Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AltiVate Anatomic Shoulder System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AltiVate Anatomic Shoulder Systemsee related information
Date Initiated by FirmJune 28, 2021
Create DateAugust 23, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2331-2021
Recall Event ID 88223
510(K)NumberK162024 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductAltiVate 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
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  
FEI Number 1000116912
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information ContactMs. Kiersten Soderman
864-322-3801
Manufacturer 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 Determined
Cause 2		Process change control
ActionOn 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.
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KWS
-
-