Date Initiated by Firm |
August 28, 2018 |
Create Date |
October 29, 2018 |
Recall Status1 |
Terminated 3 on February 04, 2021 |
Recall Number |
Z-0290-2019 |
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 131mm-191mm, Model Number 4935-0-030. 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: L18238 L13689 L22249 L26333 L31075 L31035 L35849 L35850 L45970 L46580 L47080 L46577 L46781 L47195 L49918 L49816 L51362 L53106 L53487 L53823 L53488 L56830 L56831 L57502 Y00081 Y00080 Y02872 Y02873 Y03128 Y07628 Y07630 Y08561 Y08555 Y08554 Y08553 Y12876 Y14867 Y14641 |
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 |
1355 |
Distribution |
US Nationwide in the states of CO, FL, MD, MI, NY, OK, and PA. |
Total Product Life Cycle |
TPLC Device Report
|
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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
|