FDA Medical Device Recalls (openFDA)
Stryker GmbH: Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
- Recall number
- Z-2219-2024
- Recalling firm
- Stryker GmbH
- Product
- Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
- Status
- Open, Classified
- Initiated
- 2024-05-09
- Posted
- 2024-06-27
- Terminated
- not on file
- Reason
- The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
- 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
- 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.
- Lot, serial or model codes
- Lot #J43995, UDI-DI 07613252611035.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
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