Z-2219-2024Class II

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System

Name: Z-2219-2024 Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System
Creator: Stryker GmbH
Published: 2024-05-09
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-05-09 / Open, Classified

FDA source

Stryker GmbH began a recall of Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System on 2024-05-09. FDA classified it as Class II and gives the reason as "The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2219-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-06-27
Recalling firm: Stryker Corp.
Product: Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
FDA root cause: Process change control
Action: The recalling firm issued letters dated 5/9/2024 on 5/9/2024 and 5/11/2024 via email to sales reps and distributors and via FedEx ground to hospitals. The letter described the product, the issue, and potential risks. The consignees instructions were: (1) Immediately check your inventory to locate the affected product listed on the Business Reply Form, remove the product from its point of use, and isolate it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email by 5/15/2024 to confirm receipt of the notification/documenting product disposition: (3) Upon receipt of the completed Business Reply Form, Stryker will contact the consignee to arrange for return of the product; (4) Maintain awareness of the communication internally until all required actions have been completed within the consignee facility; (5) If the consignee has further distributed the affected product, notify the applicable parties at once about the recall. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details; and if the consignee is a distributor, note that the distributor is responsible for notifying their affected customers.
Quantity in commerce: 39 devices
Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.
Product codes and lots: Lot #J43995, UDI-DI 07613252611035.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2219-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2219-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-03	2024-06-27

Product code KTT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)