Recall Z-2331-2021 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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
| Date | Jun 28, 2021 |
| Status | Open, Classified |
| 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162024 | AltiVate Anatomic Shoulder System Encore Medical L.P., Nov 21, 2016 |