Reverse Shoulder Prosthesis Screws May Have Incorrect Size
Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.
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: FDA Class II recall involving a medical device where the incorrect component could impair surgical fixation. No illnesses or injuries have been reported. Per the severity rubric, Class II recalls without reported hospitalizations with concrete risk-of-harm but no reported injuries score at the 'High' level.
Plain-English summary
Encore Medical has issued a recall of Reverse Prosthesis Shoulder System locking bone screws (5mm x 30mm, REF 506-03-130). The affected product was distributed in packages that should have contained 5mm x 30mm screws but may instead contain incorrect 3.5mm x 30mm screws.
If the incorrect screws are used during shoulder replacement surgery, they could result in surgical delay and inadequate fixation. This represents a significant surgical risk for patients receiving shoulder prostheses with these screws.
Approximately 70 units were distributed to healthcare facilities across 14 U.S. states (Florida, Indiana, Wisconsin, Iowa, Minnesota, Kentucky, New York, Arizona, Rhode Island, Washington, Ohio, South Carolina, Virginia, and Texas) and Mexico. The affected lot number is 835C2074, with an expiration date of March 9, 2029.
The recalled product
- Product
- REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- Manufacturer
- Encore Medical, LP
- Hazard
- incorrect-component
- surgical-delay
- inadequate-fixation
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)
- UDI-DI: 00888912024570
- Lot: 835C2074
- EXP: 2029-03-9
Distribution
Distributed in 14 states:
- AZ
- FL
- IA
- IN
- KY
- MN
- NY
- OH
- RI
- SC
- TX
- VA
- WA
- WI
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