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 Tornier HRS Max

  • 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 Tornier HRS Maxsee related information
Date Initiated by FirmMarch 05, 2026
Date PostedApril 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1769-2026
Recall Event ID 98512
510(K)NumberK251686 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductTornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Code Information 1. UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352 2. UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352 3. UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351
FEI Number 3000718467
Recalling Firm/
Manufacturer		 Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information ContactDannielle Stap
713-664-7222
Manufacturer Reason
for Recall		Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
FDA Determined
Cause 2		Labeling design
ActionOn March 5, 2026, the firm notified affected customers of the product issue. Customers were instructed to locate affected product in their inventory. Relevant personnel should be informed that the affected product must not be used with Tornier HRS Max products, as they are incompatible. Product return is not necessary, but customers may contact the recalling firm to arrange for return if the product issue impacts their needs.
Quantity in Commerce233
DistributionUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI.
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 = KWS
-
-