Class 2 Device Recall stryker TORNIER PERFORM

• Date Initiated by Firm: August 29, 2024
• Date Posted: September 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3155-2024
• Recall Event ID: 95258
• 510(K)Number: K220418
• Product Classification: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained - Product Code PKC
• Product: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
• Code Information: UDI/DI 00846832092192, Lot number 3268BA
• Recalling Firm/ Manufacturer: Tornier, Inc; 10801 Nesbitt Ave S; Bloomington MN 55437-3109
• For Additional Information Contact: Meghan Wells; 901-201-9298
• Manufacturer Reason for Recall: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributor were directed to notify their customers. Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributors were directed to notify their customers. For questions or concerns, please contact memphis.fieldaction@stryker.com.
• Quantity in Commerce: 5 units
• Distribution: US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = PKC