Recall Z-0117-2021 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, LP
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
| Date | Aug 31, 2020 |
| Status | Terminated |
| Reason | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. |
| Root cause | Labeling False and Misleading |
| Action | On 08/31/2020, the firm notified affected customers via email using a letter titled, "URGENT FIELD SAFETY NOTICE", indicating the following: The firm requires that you do the following actions by September 11, 2020: 1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. 2. Review your stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be pro |
| Quantity | 15 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Sm Encore Medical L.P., Oct 30, 2017 |