RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
This recall is currently active, issued November 8, 2023.
- Recall Initiated
- September 25, 2023
- Posted
- November 8, 2023
- Recall Number
- Z-0282-2024
- Quantity
- 20
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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.
Distribution
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Lot / Code Info
UDI-DI: 00888912144667, Lot: 390P1157
Root Cause
Labeling Change Control
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