Reverse Shoulder System e+ recall: Labeling Error
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Why was Reverse Shoulder System e+ recalled?
Mislabeling
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00888912144612/Lot Number(s): 381P1167
- Product
- Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- Recalling firm
- Encore Medical, LP
- Quantity
- 17 units
- Distribution
- US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
- Recall date
- January 10, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)