Reverse Shoulder Joint Implant System Recalled for Mislabeling
Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall initiated voluntarily by the manufacturer for mislabeling. No illnesses, injuries, or patient harm have been reported. With no reported adverse events and only 17 units affected, this qualifies as a minor labeling error warranting a Moderate severity rating.
Plain-English summary
Encore Medical, LP is recalling 17 units of the Reverse Shoulder System e+, model REF 509-01-032, RSP Humeral Socket Insert, Size 32mm, Semi-Constrained, from Lot Number 381P1167, UDI (01)00888912144612.
The recall was issued due to mislabeling of the product. The FDA classified this as a Class II recall. Encore Medical initiated the recall voluntarily on October 5, 2023.
The affected units were distributed nationwide to healthcare facilities in Virginia, Tennessee, Minnesota, Indiana, Rhode Island, Maine, Texas, Louisiana, Alabama, Florida, and California. Patients and healthcare providers in these states should verify whether affected devices are in their facilities and contact Encore Medical, LP or their healthcare provider for guidance regarding their specific device.
The recalled product
- Product
- Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00888912144612/Lot Number(s): 381P1167
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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