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U.S. Department of Health and Human Services

Class 2 Device Recall SMR TT Hybrid glenoid Std

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 Class 2 Device Recall SMR TT Hybrid glenoid Stdsee related information
Date Initiated by FirmFebruary 21, 2023
Date PostedApril 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1317-2023
Recall Event ID 91869
510(K)NumberK163397 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
ProductSMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Code Information UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information Contact
+390432945511
Manufacturer Reason
for Recall		Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
FDA Determined
Cause 2		Process control
ActionOn 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to pms@limacorporate.com 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to medicalcomplaints@limacorporate.com
Quantity in Commerce1
DistributionUS: MO
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
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