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
- Affected units
- 20
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
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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