REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
FDA Recall Z-2010-2023 · Posted 2023-06-27
Recalling FirmLimacorporate S.p.A
Recall StatusOpen, Classified
Product CodeMBF
Date Initiated2023-05-30
Product Quantity13 units
Reason for Recall
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Firm 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 [email protected] 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 [email protected].
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.