Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Recall
- Recall Number
- Z-0625-2024
- Event Number
- 93623
- FEI Number
- 1000116912
- Product Code
- PHX
- Status
- Completed
- Root Cause
- Packaging process control
- Initiated
- October 5, 2023
- Posted
- January 2, 2024
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Mislabeling
On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions: 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 for the items to be returned. 3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
17 units