Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- Company
- Tornier, Inc
- Recall Initiated
- May 3, 2022
- Recall Number
- Z-1216-2022
- Quantity
- 1066 units
- Firm Location
- Bloomington, MN
Reason for Recall
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Distribution
US Nationwide distribution.
Lot / Code Info
Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes
Root Cause
Device Design
Action Taken
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.