Shoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect
Encore Medical recalls RSP Glenoid Baseplate shoulder implants due to a manufacturing defect in the hex engagement mechanism. The defect could prevent proper installation of the device.
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 for a surgical implant with a manufacturing defect that could prevent proper installation. No illnesses or injuries have been reported. This qualifies as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling the RSP Glenoid Baseplate, 30mm P2 Porous Coated, a surgical shoulder implant (Part Number 508-32-204, UDI-DI Code 00888912144391). The recall affects 146 units with serial numbers 769P2825, 769P2846, and 769P2893.
The affected implants have a manufacturing defect in the coating hex that prevents proper engagement with the Straight Mod Hexdriver or Hex Head Screw Driver. This defect could impair proper installation of the device during shoulder surgery.
The affected units have been distributed to healthcare facilities in Arizona, California, Florida, Indiana, Kansas, Kentucky, Maine, Minnesota, Mississippi, New Jersey, Ohio, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Washington.
Patients and healthcare providers with affected devices should contact Encore Medical for instructions on replacement or return of the product.
The recalled product
- Product
- RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
- Manufacturer
- Encore Medical, LP
- Hazard
- assembly-defect
- improper-engagement
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 Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825
- 769P2846
- 769P2893
Distribution
Distributed in 17 states:
- AZ
- CA
- FL
- IN
- KS
- KY
- ME
- MN
- MS
- NJ
- OH
- RI
- SC
- TN
- TX
- VA
- WA
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