Recall Z-1216-2022 ยท LXH Orthopedic Manual Surgical Instrument
Tornier, Inc
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
| Date | May 3, 2022 |
| Status | Open, Classified |
| 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 w |
| Quantity | 1066 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc., Nov 15, 2016 |