Encore Medical Recalls Humeral Socket Inserts Due to Size Mismatch
Encore Medical is recalling 37 humeral socket inserts because the size etched on the product may differ from the size on the patient sticker label.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant physical impairment and revision surgery, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling 37 units of the RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440. The recall is due to a labeling error where the size etched onto the product may differ from the size information shown on the patient sticker labels.
The affected units are identified by Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, and UDI 00888912144599. These products were distributed in the United States to facilities in Virginia, Minnesota, Indiana, Rhode Island, Pennsylvania, New York, Washington, Kansas, Oklahoma, Florida, Georgia, and California.
The FDA classifies this as a Class II recall. The potential risks associated with this issue include a surgeon implanting the incorrect size, which could lead to significant physical impairment, discomfort, or disruption of treatment for the underlying condition. Additionally, patients may experience dislocation resulting in revision surgery.
The recalled product
- Product
- RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
- Manufacturer
- Encore Medical, LP
- Affected units
- 37
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 (3)
- Part 509-00-440
- Lot Numbers 387P1042A and 387P1045A
- UDI: 00888912144599
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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