REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA device recall Z-2009-2023 · posted 2023-06-27 · Open, Classified
Recall details
- Recalling firm
- Limacorporate S.p.A
- Reason for recall
- Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MBF
- Quantity affected
- 13 units
- Distribution
- US Nationwide distribution in the states of MI, IL, ND, MO, OK.
- Date initiated
- 2023-05-30
- Date posted
- 2023-06-27
- Location
- San Daniele Del Friuli, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMA TT Glenoid (K222427) | Lima Corporate S.P.A. | 2022-10-06 |