Prima 4mm Eccentrical Adaptor (Limacorporate) – Marking Missing (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
Brand
Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
Lot Codes / Batch Numbers
Lot number 2421400/UDI: 08033390201834
Products Sold
Lot number 2421400/UDI: 08033390201834
Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy is recalling PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile due to There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026