REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
This recall is currently active, issued June 27, 2023. It was issued by Limacorporate S.P.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy.
- Recall Initiated
- May 30, 2023
- Posted
- June 27, 2023
- Recall Number
- Z-2009-2023
- Quantity
- 13 units
- Official Source
- View on FDA website ↗
Reason for Recall
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Distribution
US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Lot / Code Info
UDI-DI: 08033390244824; All Lots
Root Cause
Device Design
Action Taken
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.