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U.S. Department of Health and Human Services

Class 2 Device Recall Aequalis PerFORM Reversed, Aequalis PerFORM Reversed Glenoid

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  Class 2 Device Recall Aequalis PerFORM Reversed, Aequalis PerFORM Reversed Glenoid see related information
Date Initiated by Firm May 03, 2022
Create Date June 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1216-2022
Recall Event ID 90052
510(K)Number K161742  
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Code Information Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes
Recalling Firm/
Tornier, Inc
10801 Nesbitt Ave S
Bloomington MN 55437-3109
For Additional Information Contact Meghan Wells
Manufacturer Reason
for Recall
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
FDA Determined
Cause 2
Device Design
Action The recalling firm issued recall notification letters on May 3, 2022 via UPS ground. Consignees are asked to do the following: 1. Immediately cease sterilizing the kitted Aequalis" Perform" Reversed Ratcheting Screwdriver Handle (MWJ128) in an Aesculap container. a. If sterilization in an Aesculap container is desired, the handle (MWJ128) shall be removed from the kit (YKAD261) prior to sterilization and then sterilized separately. To ensure sterility, the handle (MWJ128) must be double-wrapped and sterilized individually according to the parameters provided in the table below and provided within the new Instructions for Use online at https://ifu.stryker.com/. b. If the kit, YKAD261, contains the previous version (IFU 7638), discard the previous IFU and reference the eIFU (IFU 017) for instructions. 2. Disseminate this notice to all those who need to be aware within your organization. 3. Return the enclosed business reply form by email to confirm receipt of this notification. 4. Inform Stryker if any of the subject devices have been distributed to other organizations.
Quantity in Commerce 1066 units
Distribution US Nationwide distribution.
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 = LXH and Original Applicant = Tornier, Inc.