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

FDA device recall Z-2219-2024 · posted 2024-06-27 · Open, Classified

Recall details

Recalling firm

Stryker GmbH

Reason for recall

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

Action taken

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.

Root cause

Process change control

Status

Open, Classified

Product code

KTT

Quantity affected

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.

Date initiated

2024-05-09

Date posted

2024-06-27

Location

Selzach, Switzerland