PRIMA recallZ-2025-2025 · Limacorporate S.p.A · initiated May 19, 2025
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
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
FDA root cause category: Process design
What the company is doing
On May 19, 2025, Enovis (Limacorporate S.p.A) issued a recall notification via e-mail. Enovis provided customers with an updated notification on May 28, 2025 to provide additional information. Enovis asked consignees to take the following steps: 1. Review your stock for the products and lot numbers for the items to be returned and quarantine immediately the affected devices. 2. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3. If you have further distributed the product, please provide this recall notification to those consignees; have them complete the acknowledgement form; and notify anyone that they have further distributed the affected product to. 3. Complete the attached acknowledgement form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 4. Return all devices using the RMA number and shipping label provided by Customer Service. Devices must be sent back to: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA within 15 days together with a signed hard copy of the following acknowledgement form.
Recall details
- Recall number
- Z-2025-2025
- Status
- Open, Classified
- Initiated by the company
- May 19, 2025
- Posted by the FDA
- Jun 25, 2025
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 9 units
- Product code
- PHX
- FDA submissions
- K212800
- Distribution
- Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Product description
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Code information (models, lots, serial numbers)
Lot number 2421400/UDI: 08033390201834
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PRIMA 1367.15.704Limacorporate SPA · Shoulder Prosthesis, Reverse Configuration1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96911).
- Z-2024-2025 · Open, ClassifiedPRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
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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