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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Hoffman LRF Wire Tensioner

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 Class 2 Device Recall Stryker Hoffman LRF Wire Tensionersee related information
Date Initiated by FirmMay 09, 2024
Date PostedJune 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2219-2024
Recall Event ID 94721
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductStryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Code Information Lot #J43995, UDI-DI 07613252611035.
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
Manufacturer 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 Determined
Cause 2		Process change control
ActionThe 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 Commerce39 devices
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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