restor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
restor3d Inc. is recalling 59 Veritas Standard Glenoid Baseplates because incorrect machining of peripheral screw holes may cause improper screw engagement.
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: The recall involves a high-risk medical device with a structural defect that could lead to improper engagement, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
restor3d Inc. is voluntarily recalling 59 units of the Veritas Standard Glenoid Baseplate (Model/Catalog Numbers 1500-1030 and 1500-1035). The recall is due to incorrect machining of the peripheral screw holes, which creates a potential for improper engagement of the peripheral screws. The affected lots are A00030, A00065, A09828, A09830, A00064, and A09829.
The Veritas Standard Glenoid Baseplate is a component of the restor3d Reverse Total Shoulder Arthroplasty System, intended for patients requiring a reverse shoulder replacement. The patient-specific baseplate is not affected by this defect and is not included in this recall. The affected units were distributed nationwide in the state of Texas.
Healthcare providers and patients should contact restor3d Inc. for further instructions regarding the return or replacement of the affected baseplates.
The recalled product
- Product
- Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Description: The restor3d Reverse Total Shoulder Arthroplasty System…
- Manufacturer
- restor3d Inc.
- Affected units
- 59
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 (9)
- Lot Code: Model No 1500-1030
- UDI-DI 00840097513225
- Lot Numbers A00030
- A00065
- A09828
- A09830 Model No 1500-1035
- UDI-DI 00840097513232
- Lot Numbers A00064
- A09829
Distribution
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