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U.S. Department of Health and Human Services

Class 2 Device Recall Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate

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 Class 2 Device Recall Tornier Perform Reversed Augmented Glenoid Lateralized Baseplatesee related information
Date Initiated by FirmSeptember 15, 2023
Date PostedOctober 13, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0113-2024
Recall Event ID 93051
510(K)NumberK161742 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Productstryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Code Information UDI/DI 10846832062017, Lot Number 1756123
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information ContactMeghan Wells
713-664-7222
Manufacturer Reason
for Recall		One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
FDA Determined
Cause 2		Process change control
ActionStryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.
Quantity in Commerce30 units
DistributionUS: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
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 = PHX
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