Shoulder Glenoid Prosthesis Implant Manufactured Without Tantalum Markers
A shoulder glenoid prosthesis implant (SMR TT Hybrid Std - Peg S) was manufactured without tantalum markers that aid in radiographic visualization. While alternative assessment methods using joint space, peg position, and cement observation remain available, the missing markers limit direct imaging capabilities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries or hospitalizations. The missing markers affect radiographic visualization but do not prevent assessment, as alternative evaluation methods (joint space, peg position, cement mantel observation) are explicitly available per the source.
Plain-English summary
This recall involves the SMR TT Hybrid glenoid shoulder prosthesis implant manufactured by Limacorporate S.p.A, which was produced without tantalum markers. Tantalum markers are radiopaque components that assist in radiographic assessment of implant positioning.
On already-implanted devices lacking these markers, radiographic assessment must be performed by evaluating the joint space, central peg position, and cement mantel observation, rather than through direct visualization of the markers. This alternative assessment method remains viable for determining correct hybrid glenoid position.
The affected unit carries Lot number 2206565 with an expiration date of April 30, 2027, and was distributed in Missouri.
The recalled product
- Product
- SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- Manufacturer
- Limacorporate S.p.A
- Hazard
- missing-radiopaque-markers
- imaging-defect
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 (1)
- UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
Distribution
Distributed in 1 state:
- MO
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