PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Recall Initiated
- May 19, 2025
- Posted
- June 25, 2025
- Recall Number
- Z-2025-2025
- Quantity
- 9 units
Reason for Recall
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Distribution
Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
Lot / Code Info
Lot number 2421400/UDI: 08033390201834
Root Cause
Process design
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.