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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Hoffmann LRF Bone Transport

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  Class 2 Device Recall Stryker Hoffmann LRF Bone Transport see related information
Date Initiated by Firm February 07, 2023
Date Posted March 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1191-2023
Recall Event ID 91666
510(K)Number K153377  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Code Information Serial numbers: D32158, D32160, D32161, D32162, D32163, D32164, D34343, D34344, D40690, D41629, D41630, D41631, D44713, G16331, G16332, G16333, G26278, G29759, G29760, G32730, G32731, G32735, G45119, H30398, H30399, H66392
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Meghan Wells
901-2019298
Manufacturer Reason
for Recall		 Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod.
FDA Determined
Cause 2		 Process change control
Action The firm issue an URGENT MEDICAL DEVICE RECALLL its consignees by letter on 02/07/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to fieldaction@stryker.com to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Spread awareness of this communication internally until all required actions have been completed within your facility. 4. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so that Stryker can inform the recipients appropriately.
Quantity in Commerce 488 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = Stryker GmbH
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