PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk
PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.
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 an FDA Class II medical device recall involving a manufacturing defect in a critical orthopedic implant component. The recall is based on the risk of implant loosening or screw displacement, but no injuries or adverse events have been reported as of the recall notice.
Plain-English summary
Limacorporate S.p.A. is recalling 179 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates—shoulder implants used in reverse shoulder replacement surgery. The recalled baseplates include multiple product codes and sizes, ranging from 25mm to 28mm diameter baseplates with various wedge angle configurations.
The recall is due to a manufacturing defect affecting the baseplate's peripheral holes, which could be out of specification. This defect may cause the implant to loosen or allow the attachment screw to move from its original position, potentially compromising the function of the implant.
The affected devices were distributed to healthcare facilities in California, Illinois, Indiana, Michigan, Missouri, and Oklahoma.
Patients who received these implants should contact their surgeon or the facility where they had surgery to confirm whether their implant is affected. Healthcare providers should immediately cease use of the identified product codes and verify which devices were implanted in their patient population.
The recalled product
- Product
- PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810…
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 179
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 (10)
- Product Code/UDI-DI: 1975.14.500/08033390244824
- 1975.14.800/08033390244893
- 1975.14.510/08033390231299
- 1975.14.810/08033390244909
- 1975.14.615/08033390244848
- 1975.14.815/08033390244916
- 1975.14.865/08033390244930
- 1975.14.620/08033390231312
- 1975.14.820/08033390244923
- 1975.14.870/08033390244947
Distribution
Related recalls
Same manufacturer · Limacorporate S.p.A
See all →- HighPRIMA 4MM Eccentrical Adaptor With Screw Medical Device Recall
FDA (Devices) · 2025-07-02
- HighPRIMA 2MM Eccentrical Adaptor With Screw Sterile Medical Device
FDA (Devices) · 2025-07-02
- HighTEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
FDA (Devices) · 2025-01-01
- HighMedical Device Recall: PHYSICA HPS Tibial Liner Incorrect Labeling
FDA (Devices) · 2023-12-20
- HighOrthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes
FDA (Devices) · 2023-07-05
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighOrthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes
FDA (Devices) · 2023-07-05
- HighLimacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect
FDA (Devices) · 2023-07-05
- Highrestor3d Recalls Veritas Standard Glenoid Baseplates Due to Machining Defect
FDA (Devices) · 2026-08-26
- ModerateBiomet Shoulder Implant Recall Due to Missing Taper Adaptor
FDA (Devices) · 2015-03-04
- ModerateBiomet Shoulder Prosthesis Baseplate Packaging Error Recall
FDA (Devices) · 2020-10-21
- HighShoulder Implant Recall: RSP Glenoid Baseplate Assembly Defect
FDA (Devices) · 2023-12-20