Date Initiated by Firm |
April 26, 2017 |
Create Date |
May 25, 2017 |
Recall Status1 |
Terminated 3 on February 07, 2020 |
Recall Number |
Z-2160-2017 |
Recall Event ID |
77148 |
510(K)Number |
K153377
|
Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
|
Product |
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241
Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
|
Code Information |
Lot Numbers: J49236, V07241, V30655, V47575 and V49404 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
|
For Additional Information Contact |
Mr. Michael Van Ryn 201-831-5838
|
Manufacturer Reason for Recall |
Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts.
|
FDA Determined Cause 2 |
Device Design |
Action |
Stryker sent via FedEx an "Urgent Medical Device Recall Notification and Business Reply Form" dated April 26, 2017 to their affected customers. For questions call (201) 831-6693. |
Quantity in Commerce |
437 units |
Distribution |
US Nationwide distribution in the states of CA, FL, MD and VT |
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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