RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
FDA device recall Z-0282-2024 · posted 2023-11-08 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 20
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
- Date initiated
- 2023-09-25
- Date posted
- 2023-11-08
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE REVERSE SHOULDER PROSTHESIS (K051075) | Encore Medical L.P. | 2005-05-27 |