Recall Z-0282-2024
Encore Medical, LP · initiated September 25, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Codes / lots: UDI-DI: 00888912144667, Lot: 390P1157
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.
FDA-determined 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
Details
- Recall number
- Z-0282-2024
- Initiated
- September 25, 2023
- Posted by FDA
- November 8, 2023
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 20
- Distribution
- US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
- Recalling firm
- Encore Medical, LP, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0281-2024 Class II | RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432…Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons… | 09/25/2023Open, Classified |