Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PRIMA TT Glenoid

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall PRIMA TT Glenoidsee related information
Date Initiated by FirmMay 30, 2023
Date PostedJune 27, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2010-2023
Recall Event ID 92459
510(K)NumberK222427 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
ProductREF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Code Information UDI-DI: 08033390244893; All Lots
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information ContactRobert Gabetta
+390432945511
Manufacturer Reason
for Recall		Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA Determined
Cause 2		Device Design
ActionOn 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 in Commerce13 units
DistributionUS Nationwide distribution in the states of MI, IL, ND, MO, OK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MBF
-
-