Orthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up
Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.
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 is a Class II FDA recall of an orthopedic implant where packaging errors resulted in device mix-ups. The hazard creates a risk-of-harm scenario where surgeons could use an incorrect implant. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, classifying it as High severity.
Plain-English summary
Encore Medical, LP is recalling the RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm (Reference 509-01-436), an orthopedic shoulder implant component. Twenty units of this device were distributed to surgical centers in the United States.
During the packaging process, two different humeral socket insert devices were swapped. This means some surgical facilities may have received an incorrect device. If surgeons do not have the correct device, it could cause a delay in shoulder surgery.
The affected lot number is 390P1157 (UDI-DI: 00888912144667). The devices were distributed to surgical facilities in Minnesota, Texas, Indiana, Ohio, South Carolina, Rhode Island, Maine, New Jersey, New York, Kansas, Louisiana, Florida, and California. Healthcare facilities should check their inventory for the affected lot and remove it from use, then contact Encore Medical, LP.
The recalled product
- Product
- RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Manufacturer
- Encore Medical, LP
- Hazard
- packaging-error
- wrong-device
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: 00888912144667
- Lot: 390P1157
Distribution
Distributed in 13 states:
- CA
- FL
- IN
- KS
- LA
- ME
- MN
- NJ
- NY
- OH
- RI
- SC
- TX
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