FX SHOULDER Centered Glenosphere with Screw may contain eccentric component
FX SHOULDER is recalling 4 units of a shoulder glenosphere implant component due to potential manufacturing defects that may result in eccentric product orientation rather than the intended centered design.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall involving a potential structural defect in an orthopedic implant component. No illnesses or injuries have been reported. As a risk-of-harm product where injury has not yet been reported, this meets the criteria for a High severity rating.
Plain-English summary
FX SHOULDER is recalling Centered Glenosphere w/Screw components (REF: 115-3210) because the boxes may contain an eccentric glenosphere instead of the properly centered component as designed.
Four units of this product were distributed in New Jersey. The affected lot is U0191 with UDI-DI: 03701037309551.
Patients and healthcare providers who have received this product should contact FX SHOULDER to determine if their units are affected and to discuss appropriate corrective actions.
The recalled product
- Product
- Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
- Manufacturer
- FX SHOULDER
- Hazard
- Affected units
- 4
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: 03701037309551
- Lot: U0191
Distribution
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