Z-2025-2025Class II

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Name: Z-2025-2025 PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Creator: Limacorporate S.p.A
Published: 2025-05-19
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2025-05-19 / Open, Classified / root cause: manufacturing process

FDA source

Limacorporate S.p.A began a recall of PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile on 2025-05-19. FDA classified it as Class II and gives the reason as "There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2025-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-19
Posted: 2025-06-25
Recalling firm: Limacorporate S.p.A.
Product: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 9 units
Distribution: Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Product codes and lots: Lot number 2421400/UDI: 08033390201834

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2024-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-25
Z-2025-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-25

Product code PHX

K212800Class IIPRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. / cleared 2022-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)