HOFFMANN recallZ-2219-2024 · Stryker GmbH · initiated May 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2219-2024
- Status
- Open, Classified
- Initiated by the company
- May 9, 2024
- Posted by the FDA
- Jun 27, 2024
- Recalling firm
- Stryker GmbH
- Quantity
- 39 devices
- Product code
- KTT
- 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 description
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Code information (models, lots, serial numbers)
Lot #J43995, UDI-DI 07613252611035.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HOFFMANN 4933-9-100Stryker GmbH · Orthopedic Manual Surgical Instrument1 recall5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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