Z-1216-2022Class II

Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit

Name: Z-1216-2022 Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Creator: Tornier, Inc
Published: 2022-05-03
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2022-05-03 / Open, Classified / root cause: design

FDA source

Tornier, Inc began a recall of Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit on 2022-05-03. FDA classified it as Class II and gives the reason as "The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1216-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-03
Posted: 2022-06-01
Recalling firm: TORNIER Inc.
Product: Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Root cause tag: design
FDA 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 in commerce: 1066 units
Distribution: US Nationwide distribution.
Product codes and lots: Model: MWJ128, Ratcheting Screwdriver Handle, all lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1216-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1216-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-08	2022-06-01

Product code LXH

K161742Class IIAequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. / cleared 2016-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)