RSP Humeral Socket Inserts Swapped During Packaging by Encore Medical
Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.
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: This represents a risk-of-harm product scenario with no reported injuries or illnesses. The packaging error could prevent surgeons from having correct devices during surgery, justifying a high severity score despite the absence of actual harm to date.
Plain-English summary
Encore Medical is recalling RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus devices (Lot 954W1194) due to a packaging error in which two different humeral socket insert devices were swapped. Twenty units were affected and distributed to healthcare facilities across 13 states: Minnesota, Texas, Indiana, Ohio, South Carolina, Rhode Island, Maine, New Jersey, New York, Kansas, Louisiana, Florida, and California.
The mix-up occurred during packaging, meaning some facilities may have received an incorrect socket insert device. If the error is not detected before surgery, surgeons may not have the correct device available, which could result in a surgical delay.
Healthcare facilities that received devices from Lot 954W1194 should immediately verify their inventory and confirm device accuracy. Contact Encore Medical with any questions or concerns. Surgeons should verify they have the correct socket insert before performing shoulder procedures.
The recalled product
- Product
- RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
- Manufacturer
- Encore Medical, LP
- Hazard
- device-swap
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 (2)
- UDI-DI: 00190446257585
- Lot: 954W1194
Distribution
Distributed in 13 states:
- CA
- FL
- IN
- KS
- LA
- ME
- MN
- NJ
- NY
- OH
- RI
- SC
- TX
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27