Recall Z-0281-2024 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Encore Medical, LP
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
| Date | Nov 8, 2023 (initiated Sep 25, 2023) |
| Status | Open, Classified |
| Reason | Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. |
| Root cause | Labeling Change Control |
| Action | On 09/25/23, recall notices were emailed to Agents who were asked to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected product has been transferred. 2) Return all affected devices using the RMA number. 3) Complete and return the response form. Questions can be directed to livia.kuruvila@enovis.com |
| Quantity | 20 |
| Distribution | US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA |
| 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 |