Encore Medical Recalls Mislabeled Humeral Socket Inserts
Encore Medical is recalling 15 units of RSP Standard Humeral Socket Inserts due to size labeling discrepancies that could lead to incorrect implantation.
What this means for you
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 no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Encore Medical, LP is recalling 15 units of the RSP Standard Humeral Socket Insert, 44MM, HXe-Plus (Part No. 509-00-044). The recall was initiated because the size etched onto the product may differ from the size information shown on the patient sticker labels.
The affected units 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 specific lot number is 380P1009A, and the UDI is 00888912144568.
The FDA classifies this as a Class II recall. The primary risk is that a surgeon may implant the incorrect size of the device. This error could result in significant physical impairment, discomfort, disruption of treatment for the underlying condition, or patient dislocation requiring revision surgery. Healthcare providers should verify the size of the implant against the physical product rather than relying solely on the sticker label.
The recalled product
- Product
- RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
- Manufacturer
- Encore Medical, LP
- 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 (3)
- Part 509-00-044
- Lot 380P1009A
- UDI: 00888912144568
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Encore Medical, LP
See all →- ModerateEMPOWR 3D Knee surgical device recalled due to packaging discrepancy
FDA (Devices) · 2026-07-15
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- SevereReverse Shoulder Prosthesis Implants Recalled Over Incorrect Labeling
FDA (Devices) · 2026-03-04
- HighShoulder prosthesis humeral socket inserts recalled over incorrect implant labeling
FDA (Devices) · 2026-03-04
- SevereKnee and Humeral Socket Implants Recalled for Incorrect Labeling
FDA (Devices) · 2026-03-04
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02