FDA Medical Device Recalls (openFDA)
Tornier, Inc: Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- Recall number
- Z-1216-2022
- Recalling firm
- Tornier, Inc
- Product
- Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- Status
- Open, Classified
- Initiated
- 2022-05-03
- Posted
- not on file
- Terminated
- not on file
- Reason
- The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
- Root cause
- 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
- 1066 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes
- 510(k) numbers
- K161742
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3000718467
- Firm city
- Bloomington
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28