Encore Medical Recalls Mislabeled AltiVate Shoulder Socket Inserts
Encore Medical is recalling 15 AltiVate Reverse Small Socket Inserts due to mislabeling. The error may cause surgery delays or the need for revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text explicitly states the hazard is mislabeling leading to procedural delays or revision surgery, with no reports of serious injury or death, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Encore Medical, LP is recalling 15 units of the AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus (Part Number: 509-03-044). The recall is due to product mislabeling. The affected units are from Lot Number 964W1000 and were distributed nationwide in the United States.
The mislabeling may result in a delay in surgery, the stopping of surgery, or the need for revision surgery. These devices are intended for the treatment of patients who are candidates for shoulder arthroplasty.
Healthcare providers and patients should stop using the affected units and contact Encore Medical, LP for further instructions.
The recalled product
- Product
- AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 15
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)
- Lot Number: 964W1000
Distribution
Distributed nationwide across the United States.
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