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

FDA device recall Z-2025-2025 · posted 2025-06-25 · Open, Classified

Recall details

Recalling firm

Limacorporate S.p.A

Reason for recall

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

Action taken

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.

Root cause

Process design

Status

Open, Classified

Product code

PHX

Quantity affected

9 units

Distribution

Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.

Date initiated

2025-05-19

Date posted

2025-06-25

Location

San Daniele Del Friuli, Italy

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