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U.S. Department of Health and Human Services

Class 2 Device Recall The Hoffman LRF System

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  Class 2 Device Recall The Hoffman LRF System see related information
Date Initiated by Firm August 28, 2018
Create Date October 29, 2018
Recall Status1 Terminated 3 on February 04, 2021
Recall Number Z-0288-2019
Recall Event ID 81087
510(K)Number K163656  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or soft tissue defects Joint arthrodesis Management of communicated intra-articular fractures of the distal radius Bone transport The Hoffmann LRF System is indicated in adults for: Osteotomy Revision procedure where other treatments or devices have been unsuccessful Bone reconstruction procedures Fusions and replantations of the foot Charcot foot reconstruction Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization. Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]
Code Information Lots: L13687 L22247 L18236 L25182 L31085 L35845 L47079 L47736 L57503 Y00078 Y03126 Y07637 Y07634 Y11976 Y14639 Y14643 Y18430
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Eric Petschler
201-831-6693
Manufacturer Reason
for Recall		 The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Product Recall notification letters dated 8/28/18 were sent to customers.
Quantity in Commerce 578
Distribution US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = Stryker GmbH
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