Recall Z-2009-2023
Limacorporate S.p.A · initiated May 30, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Codes / lots: UDI-DI: 08033390244824; All Lots
Reason for recall
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA-determined 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.
Details
- Recall number
- Z-2009-2023
- Initiated
- May 30, 2023
- Posted by FDA
- June 27, 2023
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 13 units
- Distribution
- US Nationwide distribution in the states of MI, IL, ND, MO, OK.
- Recalling firm
- Limacorporate S.p.A, San Daniele Del Friuli
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2010-2023 Class II | REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RDue to manufacturing issue, their is a potential for peripheral holes to be out of specification. | 05/30/2023Open, Classified |