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U.S. Department of Health and Human Services

Class 2 Device Recall PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates

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 Class 2 Device Recall PRIMA TT Glenoid Monoblock/Modular reverse TT baseplatessee related information
Date Initiated by FirmAugust 29, 2023
Date PostedJanuary 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0726-2024
Recall Event ID 93668
510(K)NumberK222427 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
ProductPRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870
Code Information Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947
FEI Number 3008021110
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information ContactRoberto Gabetta
+390432945511
Manufacturer Reason
for Recall		Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
FDA Determined
Cause 2		Device Design
ActionOn 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions: 1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation. 2) Locate, quarantine, and return affected devices. Complete and return the response form to uscomplaint@limacorporate.com 3) Customers with questions can email the firm at medicalcomplaints@limacorporate.com
Quantity in Commerce179
DistributionUS: IL, MO, CA, IN, MI, 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
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