PRIMA TT Glenoid recallZ-2010-2023 · Limacorporate S.p.A · initiated May 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA root cause category: Device Design
What the company is doing
On May 30, 2023 LimaCorporate issued an Urgent: Medical device Recall notification via E-Mail. LimaCorporate asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices. Devices must be sent back to your Lima local reference within 15 days together with a hard copy of the attached Response Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA 2. Fill out, sign and send the attached Response Form via email to your Lima local reference at [email protected] as a confirmation that You have read and acknowledged the content of this FSN. 3. If If needed, please address any inquiry to the email address [email protected].
Recall details
- Recall number
- Z-2010-2023
- Status
- Open, Classified
- Initiated by the company
- May 30, 2023
- Posted by the FDA
- Jun 27, 2023
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 13 units
- Product code
- MBF
- FDA submissions
- K222427
- Distribution
- US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Product description
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Code information (models, lots, serial numbers)
UDI-DI: 08033390244893; All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PRIMA TT Glenoid 1975.14.800Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92459).
- Z-2009-2023 · Open, ClassifiedREF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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