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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Limacorporate S.p.A: PRIMA TT Glenoid Baseplates Recalled Due to Potential Loosening

Agency Publication Date: January 12, 2024
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Summary

Limacorporate S.p.A is recalling 179 PRIMA TT Glenoid Monoblock and Modular reverse shoulder baseplates. These medical implants may have peripheral holes that were manufactured out of specification, which can prevent screws from sitting correctly. This defect can lead to the implant loosening or the surgical screw moving from its intended position after the procedure. These devices were distributed across several U.S. states including Illinois, Missouri, California, Indiana, Michigan, and Oklahoma.

Risk

If the baseplate holes are out of specification, the surgical screws may not secure the implant properly to the bone, which can cause the shoulder implant to loosen or fail, potentially requiring additional surgery to correct.

What You Should Do

  1. Check your medical records or contact your orthopedic surgeon to determine if a PRIMA TT Glenoid Baseplate was used in your shoulder surgery. Specifically look for Product Codes: 1975.14.500, 1975.14.800, 1975.14.510, 1975.14.810, 1975.14.615, 1975.14.815, 1975.14.865, 1975.14.620, 1975.14.820, or 1975.14.870.
  2. If you have received one of these implants, contact your healthcare provider or surgeon to discuss your recovery and any necessary monitoring of the implant's stability.
  3. You may also contact the manufacturer, Limacorporate S.p.A, for further information regarding this recall and any necessary follow-up steps.
  4. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.25MM REGULAR
Model / REF:
1975.14.500
UPC Codes:
08033390244824
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28MM REGULAR
Model / REF:
1975.14.800
UPC Codes:
08033390244893
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.25MM FULL WEDGED 10-degrees
Model / REF:
1975.14.510
UPC Codes:
08033390231299
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28MM FULL WEDGED 10-degrees
Model / REF:
1975.14.810
UPC Codes:
08033390244909
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.25MM FULL WEDGED 15-degrees
Model / REF:
1975.14.615
UPC Codes:
08033390244848
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28MM FULL WEDGED 15-degrees
Model / REF:
1975.14.815
UPC Codes:
08033390244916
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28MM FULL WEDGED 15-degrees X
Model / REF:
1975.14.865
UPC Codes:
08033390244930
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.25 MM FULL WEDGED 20-degrees
Model / REF:
1975.14.620
UPC Codes:
08033390231312
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28 MM FULL WEDGED 20-degrees
Model / REF:
1975.14.820
UPC Codes:
08033390244923
Product: PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates - BASEPLATE D.28 MM FULL WEDGED 20-degrees X
Model / REF:
1975.14.870
UPC Codes:
08033390244947

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93668
Status: Active
Manufacturer: Limacorporate S.p.A
Sold By: Hospitals; Surgical Centers
Manufactured In: Italy
Units Affected: 179
Distributed To: Illinois, Missouri, California, Indiana, Michigan, Oklahoma

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.