FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
- Recall number
- Z-2010-2023
- Recalling firm
- Limacorporate S.p.A
- Product
- REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
- Status
- Open, Classified
- Initiated
- 2023-05-30
- Posted
- 2023-06-27
- Terminated
- not on file
- Reason
- Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- Root cause
- Device Design
- Action
- On May 30, 2023 LimaCorporate issued an Urgent: Medical device Recall notification via E-Mail. LimaCorporate asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices. Devices must be sent back to your Lima local reference within 15 days together with a hard copy of the attached Response Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA 2. Fill out, sign and send the attached Response Form via email to your Lima local reference at uscomplaint@limacorporate.com as a confirmation that You have read and acknowledged the content of this FSN. 3. If If needed, please address any inquiry to the email address medicalcomplaints@limacorporate.com.
- Quantity
- 13 units
- Distribution
- US Nationwide distribution in the states of MI, IL, ND, MO, OK.
- Lot, serial or model codes
- UDI-DI: 08033390244893; All Lots
- 510(k) numbers
- ["K222427"]
- PMA numbers
- not on file
- Product code
- MBF
- 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