Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
FDA Recall Z-1216-2022 · Posted None
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Recalling FirmTornier, Inc
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2022-05-03
Product Quantity1066 units
Reason for Recall
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Firm 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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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