FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Recall number
- Z-2025-2025
- Recalling firm
- Limacorporate S.p.A
- Product
- PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Status
- Open, Classified
- Initiated
- 2025-05-19
- Posted
- 2025-06-25
- Terminated
- not on file
- Reason
- There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
- 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
- 9 units
- Distribution
- Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.
- Lot, serial or model codes
- Lot number 2421400/UDI: 08033390201834
- 510(k) numbers
- ["K212800"]
- PMA numbers
- not on file
- Product code
- PHX
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28