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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Device Recall Strykersee related information
Date Initiated by FirmApril 26, 2017
Create DateMay 25, 2017
Recall Status1 Terminated 3 on February 07, 2020
Recall NumberZ-2160-2017
Recall Event ID 77148
510(K)NumberK153377 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductHoffmann 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
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactMr. 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
ActionStryker 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 Commerce437 units
DistributionUS Nationwide distribution in the states of CA, FL, MD and VT
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KTT
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